Lisata Therapeutics Inc (LSTA) 2023 Q3 法說會逐字稿

Welcome to the Lisata Therapeutics Third Quarter 2023 financial results and business update conference call. (Operator Instructions) As a reminder, this call is being recorded today, Thursday, November 2, 2023. I will now turn the call over to John Menditto, Vice President of Investor Relations, and Corporate Communications at the Lisata. Please go ahead, sir.

歡迎參加 Lisata Therapeutics 2023 年第三季財務表現與業務更新電話會議。 （操作員說明）謹此提醒，本次通話將於今天（2023 年 11 月 2 日星期四）進行錄音。我現在將通話轉給 Lisata 投資者關係和企業傳播部副總裁 John Menditto。請繼續，先生。

Thank you, Operator, and good afternoon, everyone. Welcome to Lisata's Third Quarter 2023 Conference Call to discuss our financial results and the opportunity to provide a business update. Joining me today from our management team are Dr. David Mazzo, President and Chief Executive Officer; Dr. Kristen Buck, Executive Vice President of Research and Development and Chief Medical Officer, and James Nisco, Vice President of Finance and Treasury.

謝謝接線員，大家下午好。歡迎參加 Lisata 的 2023 年第三季電話會議，討論我們的財務表現以及提供業務更新的機會。今天與我一起加入我們管理團隊的是總裁兼執行長 David Mazzo 博士；研發執行副總裁兼首席醫療官 Kristen Buck 博士，以及財務與財務副總裁 James Nisco。

Shortly before this call, we issued a press release announcing our Third Quarter 2023 financial results, which is available under the Investors and News section of the company website, along with a webcast replay of this call. If you have not received this news release or if you'd like to be added to the company's email distribution list, please email me at jmenditto@lisata.com.

在本次電話會議之前不久，我們發布了一份新聞稿，宣布了2023 年第三季的財務業績，該新聞稿可在公司網站的投資者和新聞部分查看，同時也對本次電話會議進行了網路直播重播。如果您還沒有收到本新聞稿，或希望添加到公司的電子郵件分發清單中，請發送電子郵件至 jmenditto@lisata.com。

Before we begin, I remind you that comments made by management during this conference call will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Lisata. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, its Forms 10-Q, 8-K, and 10-K, which identify specific risk factors that may cause actual results or events to differ materially from those described in the forward-looking statements.

在我們開始之前，我提醒您，管理層在本次電話會議中發表的評論將包含前瞻性陳述，這些陳述涉及 Lisata 的營運和未來績效的風險和不確定性。我鼓勵您查看該公司向美國證券交易委員會提交的文件，包括但不限於其表格 10-Q、8-K 和 10-K，其中確定了可能導致實際結果或事件出現重大差異的特定風險因素來自前瞻性陳述中所描述的內容。

Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, Thursday, November 2, 2023. Lisata Therapeutics undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. With that, I will now turn the call over to Dr. David Mazzo. Dave?

此外，本次電話會議的內容包含時間敏感的信息，僅截至本次直播之日（2023 年11 月2 日星期四）準確。Lisata Therapeutics 不承擔修改或更新任何聲明以反映之後發生的事件或情況的義務。本次電話會議的日期。現在，我將把電話轉給大衛·馬佐博士。戴夫？

Thank you, John, and good afternoon, everyone. Thank you for joining us today as we provide an overview of recent business highlights, discuss our third quarter 2023 financial results, and give an update on the progress of our various development programs.

謝謝約翰，大家下午好。感謝您今天加入我們，我們將概述最近的業務亮點，討論我們的 2023 年第三季財務業績，並提供我們各種開發計劃的最新進展。

The third quarter was another productive quarter for Lisata as we added to the momentum of the first half of 2023 with the initiation and advancement of new clinical development programs targeting a variety of advanced solid tumors using LSTA1, our lead product candidate, in combination with multiple anti-cancer agents of differing modalities.

第三季度是 Lisata 另一個富有成果的季度，我們利用我們的主要候選產品 LSTA1 結合多種藥物啟動和推進了針對各種晚期實體瘤的新臨床開發項目，為 2023 年上半年增添了動力。不同形式的抗癌劑。

As we have previously reported, we have both preclinical data and early clinical data in humans that we believe demonstrates the potential of LSTA1 to become an integral part of a revised standard of care treatment regimen for many difficult-to-treat cancers. Following this call, our Chief Medical Officer, Dr. Kristen Buck, will provide an update on our clinical programs following the review of our financial results. And with that, I now will turn the call over to James Nisco, our Vice President of Finance and Treasury. James?

正如我們先前所報導的，我們擁有人類的臨床前數據和早期臨床數據，我們相信這些數據證明了 LSTA1 有潛力成為許多難治性癌症的修訂護理治療方案標準的組成部分。在這次電話會議之後，我們的首席醫療官 Kristen Buck 博士將在審查我們的財務表現後提供我們臨床項目的最新資訊。現在，我將把電話轉給我們的財務和財政部副總裁詹姆斯·尼斯科 (James Nisco)。詹姆士？

Thanks, Dave. Good afternoon, all. I'm pleased to join you today to present a summary of our third quarter 2023 financial results, starting with operating expenses. For the three months ended September 30, 2023, operating expenses totalled $6 million compared to $37.7 million for the three months ended September 30, 2022, representing a decrease of 84.2%. Excluding the in-process research and development expense of $30.4 million related to our merger with Cent Therapeutics in September 2022, operating expenses decreased by $1.4 million, or 18.6%, compared to the three months ended September 30, 2022.

謝謝，戴夫。大家下午好。我很高興今天與大家一起介紹我們 2023 年第三季的財務業績摘要，首先是營運費用。截至2023年9月30日止三個月，營運費用總計600萬美元，截至2022年9月30日止三個月為3,770萬美元，下降84.2%。不包括與2022 年9 月與Cent Therapeutics 合併相關的3,040 萬美元的正在進行的研發費用，與截至2022 年9 月30 日止的三個月相比，營運費用減少了140 萬美元，即18.6% 。

Operating expenses comprised the following. Research and development expenses were approximately $3.4 million for the three months ended September 30, 2023, compared to $3.3 million for the three months ended September 30, 2022, representing an increase of 1.3%. Expenses this quarter were primarily due to study activities associated with the BOLSTER trial here in the United States, enrolment activities for the ASCEND study in Australia.

營運費用包括以下內容。截至2023年9月30日止三個月的研發費用約為340萬美元，而截至2022年9月30日止三個月的研發費用為330萬美元，成長1.3%。本季的費用主要是因為與美國 BOLSTER 試驗相關的研究活動以及澳洲 ASCEND 研究的招募活動。

startup activities for the glioblastoma multiforme study in Europe, and general chemistry, manufacturing, and control activities for LSTA1 to support all development activities. General and administrative expenses were approximately $2.6 million for the three months ended September 30, 2023, compared to $4.0 million for the three months ended September 30, 2022, representing a decrease of $1.4 million, or 35.3%.

歐洲多形性膠質母細胞瘤研究的啟動活動，以及 LSTA1 的一般化學、製造和控制活動，以支持所有開發活動。截至2023年9月30日止三個月的一般及行政費用約為260萬美元，而截至2022年9月30日止三個月的一般及行政費用約為400萬美元，減少140萬美元或35.3%。

This was primarily due to non-recurring merger-related costs in the prior year, a decrease in equity expense due to prior year performance stock unit vesting, merger option assumption expense, and departing board member restricted stock unit vesting, and timing of our annual stockholder meeting versus the prior year. Overall, net losses were $5.3 million for the three months ended September 30, 2023, compared to $37.4 million for the three months ended September 30, 2022.

這主要是由於前一年的非經常性合併相關成本、上一年績效股票單位歸屬導致的股權費用減少、合併選擇權假設費用、離任董事會成員限制性股票單位歸屬以及我們年度股東大會的時間安排。股東大會與上一年的比較。整體而言，截至2023年9月30日止三個月的淨虧損為530萬美元，而截至2022年9月30日止三個月的淨虧損為3,740萬美元。

Excluding the in-process research and development expense of $30.4 million related to our merger with Cend Therapeutics in September 22, net losses for the three months ended September 30, 2023, decreased by $1.7 million, or 24.7%, compared to the three months ended September 30, 2022.

不包括與9 月22 日與Cend Therapeutics 合併相關的3,040 萬美元的研發費用，截至2023 年9 月30 日止三個月的淨虧損較截至2023 年9 月30 日止三個月減少170 萬美元，即24.7% 2022 年 9 月 30 日。

Turning now to our balance sheet and cash flow, as of September 30, 2023, the company had cash, cash equivalents, and marketable securities of approximately $54.4 million. The company remains confident that its projected capital will fund its current and proposed operations into early 2026, encompassing anticipated data milestones from all its ongoing and planned clinical trials.

現在來看看我們的資產負債表和現金流，截至 2023 年 9 月 30 日，該公司擁有約 5,440 萬美元的現金、現金等價物和有價證券。該公司仍然相信，其預計資本將為其當前和擬議的營運提供資金直至 2026 年初，其中包括所有正在進行和計劃中的臨床試驗的預期數據里程碑。

This completes my financial overview, and I will now turn the call over to our Chief Medical Officer, Dr. Kristen Buck, for the review of our clinical development pipeline. Kristen?

我的財務概覽到此結束，現在我將把電話轉給我們的首席醫療官 Kristen Buck 博士，以審查我們的臨床開發管道。克里斯汀？

Thank you, James, and good afternoon, everyone. As those who have been following us know, Lisata's pipeline is built on a portfolio of proprietary and patented technology that is grounded in strong scientific rationale and a body of published preclinical and early clinical data.

謝謝詹姆斯，大家下午好。正如一直關注我們的人所知，Lisata 的管道建立在一系列專有和專利技術的基礎上，這些技術基於強有力的科學原理和大量已發表的臨床前和早期臨床數據。

Our platform technology is designed to address major impediments to the successful treatment of advanced solid tumors in an environment of increasing pharmacoeconomic pressures. Generating meaningful clinical data is critically important in this field, and I can assure you that our entire organization has this goal top of mind in everything we do.

我們的平台技術旨在解決在藥物經濟壓力日益增加的環境下成功治療晚期實體瘤的主要障礙。產生有意義的臨床數據在該領域至關重要，我可以向您保證，我們整個組織在所做的一切事情中都將這一目標放在首位。

With that, I will now provide an overview of LSTA1 for the treatment of advanced solid tumors in combination with other anti-cancer agents. Despite advances in cancer therapy today, many solid tumors remain difficult to treat effectively. Cancers such as pancreatic cancer, gastric cancers, and other solid tumors are surrounded by a dense fibrotic tissue known as the stroma, which limits access of most pharmacotherapies to the tumor.

現在，我將概述 LSTA1 與其他抗癌藥物合併治療晚期實體瘤的情況。儘管當今癌症治療取得了進步，但許多實體腫瘤仍然難以有效治療。胰臟癌、胃癌和其他實體瘤等癌症被稱為基質的緻密纖維化組織包圍，這限制了大多數藥物療法對腫瘤的影響。

Many tumors also have a hostile tumor microenvironment, or TME, which suppresses a patient's immune system and makes it less effective in fighting cancer. The combination of a dense stroma and a hostile tumor microenvironment prevents many chemotherapies and immunotherapies from being optimally effective in treating these cancers. This, coupled with the fact that most anti-cancer therapies are not efficient in targeting only cancerous tissue, defines the major challenge of maximizing effectiveness and safety in the treatment of solid tumors.

許多腫瘤也具有不利的腫瘤微環境（TME），它會抑制患者的免疫系統，使其對抗癌症的效果降低。緻密基質和惡劣的腫瘤微環境的結合阻礙了許多化療和免疫療法在治療這些癌症方面發揮最佳效果。再加上大多數抗癌療法不能有效地僅針對癌組織這一事實，確定了最大化實體瘤治療的有效性和安全性的主要挑戰。

To combat this, Lisata's approach is to activate the C-end rule or CendR system, a naturally occurring active transport system to selectively deliver anti-cancer drugs through the stroma and into the tumor. Lisata's lead product candidate, LSTA1, the recipient of multiple orphan designations, including for pancreatic cancer in both the United States and Europe, as well as for malignant glioma in the United States,

為了解決這個問題，Lisata 的方法是活化 C 端規則或 CendR 系統，這是一種天然存在的主動轉運系統，可以選擇性地將抗癌藥物透過基質輸送到腫瘤中。 Lisata 的主要候選產品 LSTA1 獲得了多項孤兒藥物指標，包括美國和歐洲的胰腺癌以及美國的惡性神經膠質瘤，

Is an investigational drug that actuates the CendR active transport mechanism while also having the potential to modify the tumor microenvironment and make it less immunosuppressive. LSTA1 targets tumor vascular endothelial cells as well as tumor cells themselves based on its affinity for alpha-v, beta-3, and beta-5 integrins that are selectively upregulated on these cells in comparison to healthy tissue.

是一種研究藥物，可啟動 CendR 主動轉運機制，同時也具有改變腫瘤微環境並降低其免疫抑制的潛力。 LSTA1 基於其對 α-V、β-3 和 β-5 整合素的親和力，靶向腫瘤血管內皮細胞以及腫瘤細胞本身，與健康組織相比，這些細胞上的這些細胞選擇性上調。

LSTA1 is a nine amino acid cyclic internalizing RGD peptide that, once bound to these integrins, is cleaved by proteases expressed in the tumor microenvironment to release a linear peptide fragment called a CendR fragment. The CendR fragment has high affinity for and then binds to an adjacent receptor called neuropilin-1, also upregulated on tumor vascular endothelial cells and tumor cells, to activate the C-end rule active transport pathway and ferry anti-cancer drugs more efficiently into solid tumors.

LSTA1 是一種九個胺基酸的環狀內化 RGD 勝肽，一旦與這些整合素結合，就會被腫瘤微環境中表現的蛋​​白酶裂解，釋放出稱為 CendR 片段的線性勝肽片段。 CendR片段對鄰近的稱為neuropilin-1的受體具有高親和力，然後與其結合，該受體在腫瘤血管內皮細胞和腫瘤細胞上也上調，從而激活C端規則主動轉運途徑，並將抗癌藥物更有效地運送到固體中腫瘤。

Additionally, LSTA1 has been shown in a range of preclinical models to modify the tumor microenvironment, making it less hostile to immune cells, reducing tumor resistance to anti-cancer medications, and impeding and or preventing the metastatic cascade. These results come internally from Lisata and from collaborators and research groups around the world and have been the subject of over 300 related scientific publications.

此外，LSTA1 已在一系列臨床前模型中被證明可以改變腫瘤微環境，降低其對免疫細胞的敵意，降低腫瘤對抗癌藥物的抗藥性，並阻止和/或預防級聯轉移。這些結果來自 Lisata 內部以及世界各地的合作者和研究小組，並已成為 300 多份相關科學出版物的主題。

Along with our collaborators, we also have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. To date, LSTA1 has demonstrated favorable safety, tolerability, and activity to enhance delivery of standard-of-care chemotherapy for patients with metastatic pancreatic cancer. Our development programs are designed to exploit the potential of LSTA1 to enhance a variety of anti-cancer treatment modalities in a range of solid tumors.

我們與合作者一起也累積了重要的非臨床數據，證明一系列新興抗癌療法的交付得到了增強，包括免疫療法和基於 RNA 的療法。迄今為止，LSTA1 已表現出良好的安全性、耐受性和活性，可增強轉移性胰腺癌患者的標準護理化療的效果。我們的開發計畫旨在利用 LSTA1 的潛力來增強一系列實體瘤的多種抗癌治療方式。

Currently, LSTA1 is the subject of about a dozen planned or active clinical trials globally for the treatment of various solid tumors. Let me touch on a few of these individually. The ASCEND trial is a 155-patient, double-blind, randomized, placebo-controlled clinical trial evaluating LSTA1 in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma, also known as MPACT.

目前，LSTA1 是全球大約十幾個計劃或正在進行的治療各種實體瘤的臨床試驗的主題。讓我分別談談其中的一些。 ASCEND 試驗是一項 155 名患者參與的雙盲、隨機、安慰劑對照臨床試驗，評估 LSTA1 合併吉西他濱和白蛋白結合型紫杉醇治療轉移性胰臟導管腺癌（也稱為 MPACT）患者。

The trial is being conducted at up to 40 sites in Australia and New Zealand, led by the Australasian Gastrointestinal Clinical Trials Group, or AGITG, in collaboration with the NHMRC Clinical Trial Center at the University of Sydney. As previously reported in September, a positive outcome from the planned interim futility analysis was announced by the study's Independent Data Safety Monitoring Committee, which recommended continuation of the study without modification.

該試驗由澳洲胃腸臨床試驗小組 (AGITG) 牽頭，與雪梨大學 NHMRC 臨床試驗中心合作，在澳洲和紐西蘭多達 40 個地點進行。正如九月之前報導的那樣，該研究的獨立資料安全監測委員會宣布了計劃中的中期無效性分析的積極結果，該委員會建議繼續進行該研究而不需修改。

In addition, we are excited to report that full enrollment in Cohort A of ASCEND has been achieved and that overall enrollment in the study is now approximately 95% complete. With that, we now project to have top-line data from Cohort A as early as the fourth quarter of next year, a full year earlier than originally anticipated.

此外，我們很高興地報告，ASCEND A 組的全部入組已經實現，而該研究的總體入組現已完成約 95%。因此，我們現在預計最早將於明年第四季獲得 A 組的頂線數據，比最初預期早了一整年。

We plan to use the results of the ASCEND trial to explore possible conditional approvals in several jurisdictions and to design an optimized Phase III program in MPACT. The BOLSTER trial is a Phase IIa, double-blind, placebo-controlled, multi-center, randomized basket trial with investigational sites planned in the United States, Europe, Canada, and Asia, evaluating LSTA1 in combination with standards of care in advanced solid tumors, including head and neck, esophageal, and cholangiocarcinoma.

我們計劃利用 ASCEND 試驗的結果探索多個司法管轄區可能的有條件批准，並在 MPACT 中設計優化的 III 期計劃。 BOLSTER 試驗是一項 IIa 期、雙盲、安慰劑對照、多中心、隨機籃子試驗，計劃在美國、歐洲、加拿大和亞洲進行研究，結合晚期實體瘤的護理標準來評估 LSTA1腫瘤，包括頭頸癌、食道癌和膽管癌。

This trial will include both cytotoxic and immunotherapy standards of care. As previously announced, patients have now been treated in the head and neck squamous cell carcinoma and cholangiocarcinoma cohorts, and we expect a first patient in the esophageal cancer cohort by early next year.

該試驗將包括細胞毒性和免疫治療護理標準。正如先前宣布的那樣，頭頸鱗狀細胞癌和膽管​​癌隊列中的患者現已接受治療，我們預計明年初將出現食道癌隊列中的第一位患者。

CENDIFOX, the Phase Ib, IIa, open-label trial in the United States evaluating LSTA1 in combination with neoadjuvant FOLFIRINOX-based therapies in pancreatic, colon, and appendiceal cancers continues to make steady progress with approximately 80% of the overall target number of subjects in the study enrolled.

CENDIFOX 是在美國進行的Ib、IIa 期開放標籤試驗，評估LSTA1 與基於FOLFIRINOX 的新輔助療法聯合治療胰腺癌、結腸癌和闌尾癌的效果，該試驗繼續取得穩步進展，受試者總數約佔總體目標人數的80%參與的研究中。

We expect enrollment completion of the pancreatic cohort during the fourth quarter of this year and completion of the remaining two cohorts over the next two quarters with data readout in pancreatic cancer in late 2024. This trial will provide us with pre- and post-treatment biopsy, immunoprofiling data, as well as long-term outcome data. LSTA1 is also being evaluated in combination with gemcitabine and nab-paclitaxel in a Phase Ib, IIa, open-label trial in China led by our licensee in that territory, Qilu Pharmaceutical.

我們預計胰臟隊列的入組將在今年第四季度完成，其餘兩個隊列將在接下來的兩個季度完成，並於2024 年末讀出胰腺癌的數據。該試驗將為我們提供治療前和治療後的活檢、免疫分析數據以及長期結果數據。 LSTA1 也在中國的 Ib、IIa 期開放標籤試驗中與吉西他濱和白蛋白結合型紫杉醇聯合進行評估，該試驗由我們在該地區的被許可方齊魯製藥領導。

During the 2023 ASCO annual meeting, Qilu Pharmaceutical presented an abstract sharing preliminary data from the study which corroborated previously reported findings from the Phase Ib, IIa trial of LSTA1 plus gemcitabine and nab-paclitaxel conducted in Australia in patients with metastatic pancreatic ductal adenocarcinoma. Final data are expected by the end of the second quarter of 2024.

在2023年ASCO年會上，齊魯製藥提交了一份摘要，分享了該研究的初步數據，證實了先前報告的在澳洲針對轉移性胰腺導管腺癌患者進行的LSTA1聯合吉西他濱和白蛋白結合型紫杉醇Ib、IIa期試驗的結果。最終數據預計將於 2024 年第二季末公佈。

In collaboration with our funding partner, WARPNINE, the iLSTA trial is a Phase Ib, IIa randomized single-blind, single-center safety and pharmacodynamics study in Australia.

iLSTA 試驗是與我們的資助合作夥伴 WARPNINE 合作在澳洲進行的一項 Ib、IIa 期隨機單盲、單中心安全性和藥效學研究。

Evaluating LSTA1 in combination with the checkpoint inhibitor durvalumab plus standard of care chemotherapy, nab-paclitaxel, and gemcitabine versus standard of care alone in patients with locally advanced non-resectable pancreatic ductal adenocarcinoma. Enrollment completion is expected during 2024.

評估 LSTA1 與檢查點抑制劑 durvalumab 合併標準護理化療、白蛋白結合型紫杉醇和吉西他濱與單獨標準護理治療局部晚期不可切除胰腺導管腺癌患者的比較。預計註冊將於 2024 年完成。

iGoLSTA, a Phase Ib, IIa proof-of-concept safety and early efficacy study evaluating LSTA1 in combination with nivolumab and FOLFIRINOX as a first-line treatment in locally advanced non-resectable gastroesophageal adenocarcinoma is still pending initiation as a function of availability of funding by our partner, WARPNINE. We hope to have further update on timing related to the execution of the study in coming quarters.

iGoLSTA 是一項Ib、IIa 期概念驗證安全性和早期療效研究，評估LSTA1 聯合納武單抗和FOLFIRINOX 作為局部晚期不可切除胃食道腺癌的一線治療藥物，該研究仍在等待啟動，具體取決於資金的可用性由我們的合作夥伴 WARPNINE 提供。我們希望在未來幾個季度獲得與執行該研究相關的時間表的進一步更新。

We are also poised to initiate the study of LSTA1 in combination with temozolomide in glioblastoma multiforme, or GBM. This study is designed as a Phase IIa double-blind, placebo-controlled randomized proof-of-concept study evaluating LSTA1 when added to standard of care temozolomide versus temozolomide and matching LSTA1 placebo in subjects with newly diagnosed glioblastoma multiforme.

我們也準備啟動 LSTA1 合併替莫唑胺治療多形性膠質母細胞瘤 (GBM) 的研究。這項研究被設計為IIa 期雙盲、安慰劑對照隨機概念驗證研究，在新診斷的多形性膠質母細胞瘤受試者中評估將LSTA1 添加到替莫唑胺標準治療中與替莫唑胺的比較，以及匹配LSTA1 安慰劑。

It will be conducted across multiple sites in Estonia and Latvia and is targeted to enroll 30 patients with a randomization of 2:1, LSTA1 plus standard of care versus placebo plus standard of care. We are pleased to report that the EU clinical trial application has been approved and we expect the first patient treated before the end of this calendar year. Importantly, as recently announced, LSTA1 has been granted orphan designation by the US. Food and Drug Administration for malignant glioma.

它將在愛沙尼亞和拉脫維亞的多個地點進行，目標是以 2:1 的隨機比例招募 30 名患者，LSTA1 加標準護理與安慰劑加標準護理。我們很高興地報告，歐盟臨床試驗申請已獲得批准，我們預計第一名患者將在今年年底前接受治療。重要的是，正如最近宣布的，LSTA1 已被美國授予孤兒藥稱號。美國食品藥物管理局針對惡性神經膠質瘤。

This action by the FDA not only highlights the unmet medical need, but also recognizes the potential of LSTA1 to benefit patients in this indication. Lastly, we also plan to initiate a study of LSTA1 in combination with hyperthermia intraperitoneal chemotherapy, more commonly referred to as HIPEC. Interoperative intraperitoneal lavage in peritoneal carcinomatosis, a cancer that develops as a result of contiguous spread of primary cancers such as ovarian, colorectal, and appendiceal along the peritoneum.

FDA 的這項行動不僅凸顯了未滿足的醫療需求，而且還認識到 LSTA1 使該適應症患者受益的潛力。最後，我們還計劃啟動一項 LSTA1 合併腹腔熱灌注化療（通常稱為 HIPEC）的研究。腹膜癌病的術中腹腔灌洗，腹膜癌病是由於原發性癌症（如卵巢癌、大腸直腸癌和闌尾癌）沿著腹膜連續擴散而形成的癌症。

The study will be a Phase I single center unblinded randomized controlled trial to determine the safety and tolerability of LSTA1 administered intraperitoneally in patients with peritoneal metastases from colorectal, appendiceal, or ovarian cancer undergoing cytoreductive surgery and HIPEC. 21 total participants will be randomized 2:1 to receive LSTA1 with HIPEC versus HIPEC alone after cytoreductive surgery.

該研究將是一項 I 期單中心非盲隨機對照試驗，旨在確定接受細胞減滅術和 HIPEC 的結直腸癌、闌尾癌或卵巢癌腹膜轉移患者腹腔注射 LSTA1 的安全性和耐受性。總共 21 名參與者將以 2:1 的比例隨機分配，接受 LSTA1 合併 HIPEC 治療或在細胞減滅術後單獨接受 HIPEC 治療。

We anticipate the first patient will be treated in the fourth quarter of 2023. For those who are interested, a more complete description of each of our trials is available in the appendix section of the corporate presentation on our website. Additionally, in the body of the presentation, there are two milestone slides that depict the anticipated timing of key execution milestones and data readouts from our trials. With that, I will now turn the call back to Dave.

我們預計第一位患者將於 2023 年第四季度接受治療。對於有興趣的人，我們網站上公司簡報的附錄部分提供了我們每項試驗的更完整描述。此外，在簡報的正文中，有兩張里程碑幻燈片，描述了關鍵執行里程碑的預期時間和我們試驗中的資料讀數。現在，我將把電話轉回給戴夫。

Thank you, Kristen. In the last three and nine months of 2023, we have made notable progress on several fronts, including the broad application of LSTA1 in combination with a variety of anti-cancer agents for the treatment of a variety of solid tumor types. To maximize impact and confidence in the results, we have designed our studies to be scientifically and medically rigorous and to provide results expeditiously while also assuring that we are operating in a maximally capital-efficient manner.

謝謝你，克里斯汀。在2023年的最後三個月和九個月裡，我們在幾個方面取得了顯著進展，包括LSTA1與多種抗癌藥物聯合用於治療多種實體瘤類型的廣泛應用。為了最大限度地提高結果的影響力和信心，我們的研究設計具有科學性和醫學上的嚴謹性，能夠迅速提供結果，同時確保我們以最大程度的資本效率運作。

Now, with more than two years of capital available on our balance sheet, we believe we are well positioned to focus on the execution of our development plans and to achieve our goal of getting meaningful clinical data readouts as soon as possible. And with that, operator, we're ready to take questions.

現在，我們的資產負債表上有兩年多的可用資金，我們相信我們有能力專注於執行我們的發展計劃，並實現我們盡快獲得有意義的臨床數據讀數的目標。接線員，我們已經準備好回答問題了。

(Operator Instructions) Steve Brozak of WBB Securities.

（操作員指令）WBB 證券的 Steve Brozak。

Thank you for taking the question. I actually have one, but a follow-up as well because they're related. You've gone over a lot of trial descriptions. How would you describe as the meaning, the import of what these designations that you've been describing are to the trialing system? And I've got a follow-up after that, please.

感謝您提出問題。我實際上有一個，但也有一個後續，因為它們是相關的。您已經閱讀了許多試驗說明。您如何描述您所描述的這些名稱對試驗系統的意義和重要性？之後我會進行後續跟進。

Thanks, Steve. Appreciate the question. So, you know, I think actually it's a very pertinent question because in the industry, we toss around the nomenclature of orphan drug designation and fast-track designation pretty freely. And I think most people might have at least a partial understanding, but I think it's worthwhile explaining.

謝謝，史蒂夫。感謝這個問題。所以，你知道，我認為實際上這是一個非常相關的問題，因為在行業中，我們非常自由地討論孤兒藥指定和快速通道指定的術語。我認為大多數人可能至少有部分理解，但我認為這是值得解釋的。

So, let's start with fast-track designation. Fast-track designation allows the applicant, that would be for, you know, a given product and a given indication to be eligible for accelerated approval consideration and for a more rapid review cycle with the FDA, both of which are extremely beneficial in terms of getting to market faster. It also allows for more interaction with FDA in a specialized way.

那麼，讓我們從快速通道指定開始。快速通道指定使申請人（您知道，特定產品和特定適應症）有資格獲得 FDA 的加速批准考慮和更快速的審查週期，這兩者在以下方面都非常有利：更快地進入市場。它還允許以專門的方式與 FDA 進行更多互動。

And similarly, orphan drug designation, first of all, it points to the fact that the indication will have less than 200,000 patients in a given year diagnosed with that particular indication. And as a result, it's also eligible for more rapid review cycles, more rapid and consistent interaction with the agency.

同樣，孤兒藥稱號首先表明該適應症在某一年診斷出該特定適應症的患者人數將少於 20 萬人。因此，它也有資格獲得更快速的審查週期，與該機構進行更快速和一致的互動。

Importantly, you're also eligible to receive grants from the orphan drug division of FDA to develop your products because often they're not as commercially lucrative. And finally, you get an extended period of exclusivity in the market. So, that is in addition to patent protection, you have some market exclusivity. So, they're actually quite valuable designations. They're not given out freely.

重要的是，您還有資格獲得 FDA 孤兒藥部門的資助來開發您的產品，因為它們通常沒有那麼商業利潤豐厚。最後，您將獲得長期的市場獨佔權。因此，除了專利保護之外，您還擁有一些市場獨佔權。所以，它們實際上是非常有價值的名稱。它們不是免費贈送的。

It's not something that you just make an application and you're guaranteed a result, but there's a pretty critical review process. And we were very pleased that the FDA and the EU have granted orphan drug designation for mPDAC to LSTA1 and also for GBM for LSTA1 here in the United States.

這並不是說你只要提出申請就可以保證得到結果，而是有一個非常嚴格的審查過程。我們非常高興 FDA 和歐盟在美國授予 LSTA1 的 mPDAC 孤兒藥稱號，以及 LSTA1 的 GBM 孤兒藥稱號。

Okay. And that actually highlights the next follow-up and I'll hop back in the queue. Thank you. You've got these designations which are obviously significant. You've got multiple programs running with quantifiable endpoints. You've been pretty much delivering on everything you said you were looking to do. Obviously, the market isn't really viewing or understands this.

好的。這實際上突出了下一個後續行動，我將跳回隊列中。謝謝。這些稱號顯然意義重大。您已經執行了多個具有可量化端點的程式。你幾乎已經實現了你所說的你想做的一切。顯然，市場並沒有真正看到或理解這一點。

What are your thoughts around on your market cap and specifically your stock price given your execution? What do you think it is? And thanks. And I'll hop back in the queue.

您對您的市值，特別是考慮到您的執行情況的股價有何看法？你覺得它是什麼？謝謝。我會跳回到隊列中。

Okay. Well, thanks, Steve. I actually appreciate the opportunity to address that somewhat forthrightly because it's something that's on everybody's mind. There's a clear inconsistency with the advanced stage of our clinical programs, the positive data we've generated, our financial position, and the fact that we continue to execute according to plan and that the plan is rather comprehensive and a rather low market cap.

好的。嗯，謝謝，史蒂夫。事實上，我很高興有機會坦率地解決這個問題，因為這是每個人都關心的問題。這與我們的臨床項目的後期階段、我們產生的積極數據、我們的財務狀況以及我們繼續按計劃執行以及該計劃相當全面且市值相當低的事實存在明顯的不一致。

In fact, anyone can look and see we're trading roughly at somewhere between 35% and 40% of our cash on hand, which is just irrational. I think we have a couple of explanations for that. Part of it is that the entire biotech market has suffered considerably since the beginning of the year with high interest rates and everybody's stock is down. But in our particular case, there are a few unique characteristics that I think are impeding a stock advance within the short term, but that I think are available to be overcome in the long term.

事實上，任何人都可以看到我們的交易金額大約是手頭現金的 35% 到 40%，這是不合理的。我認為我們對此有幾個解釋。部分原因是，自今年年初以來，整個生技市場因高利率而遭受了相當大的打擊，而且每個人的股票都在下跌。但就我們的具體情況而言，我認為有一些獨特的特徵在短期內阻礙了股票的上漲，但我認為從長遠來看可以克服這些特徵。

One of those is that we are fortunate to have a large body of our shareholders. By our calculation, in rough terms, about two-thirds of our shareholders are long-only holders. These are people who have bought into the company either when it was in its private stages or at the time of our recent merger or in recent financing, but did so because they believe in the potential of the programs. And in order to see the programs reach their maximum value, they are not trading the stock.

其中之一是我們很幸運擁有大量股東。根據我們的粗略計算，大約三分之二的股東是多頭持有者。這些人要么在公司處於私有階段，要么在我們最近的合併或最近的融資時購買了該公司的股票，但這樣做是因為他們相信這些項目的潛力。為了讓這些計劃發揮最大價值，他們不會交易股票。

They're ignoring the fluctuations in stock price and in the market. They're treating us much like they would treat an investment in a private company, and they're sitting back and waiting for the, in inverted commas, pivotal data to come out of these trials. And so with a very little float, that is a very small fraction of our shareholders trading actively on any given day, there's not really an opportunity for a market to be made for our stock.

他們忽略了股價和市場的波動。他們對待我們就像對待私人公司的投資一樣，他們正在等待這些試驗中出現的關鍵數據（用引號引起來）。因此，由於流通量很小，在任何一天活躍交易的股東中只佔很小一部分，因此我們的股票實際上沒有機會形成市場。

There's not a lot of people who are buying or selling. And those very few who do, we trade on average 20,000 to 25,000 shares a day out of over 8 million outstanding. It's a very volatile situation. So I think, you know, our opinion is that that will change based on two things.

買或賣的人不多。對於極少數這樣做的人，我們平均每天交易 20,000 至 25,000 股，交易量超過 800 萬股。這是一個非常不穩定的情況。所以我認為，我們的觀點是，這將基於兩件事而改變。

As we get to data, which as those who have looked at our milestone slide will see is going to be occurring throughout 24 and 25, and also as we then are able to announce additional business development deals and ultimately do another financing which will allow larger funds to enter the stock because they can't do so on the market because of the low trading volume, I think we'll see that all change.

當我們獲得數據時，正如那些看過我們里程碑幻燈片的人將看到的那樣，這將在24 日和25 日期間發生，而且我們隨後能夠宣布額外的業務開發交易，並最終進行另一筆融資，這將允許更大的資金進入股票，因為交易量低，他們無法在市場上這樣做，我認為我們會看到這一切發生變化。

But like most people right now in the biotech world, the real focus is on impeccable execution to data, generating as close to unambiguous data as possible, and then letting the product for themselves. So that's what we believe is the problem.

但就像目前生技領域的大多數人一樣，真正的重點是對數據的完美執行，產生盡可能接近明確的數據，然後讓產品為自己服務。這就是我們認為的問題所在。

There's certainly no issue with the fundamentals of our company, the execution, or our plan which has been scrutinized pretty thoroughly by a lot of potential partners who are also just sitting there waiting for us to show data.

我們公司的基本面、執行情況或我們的計劃當然沒有問題，我們的計劃已經被許多潛在合作夥伴徹底審查過，他們也只是坐在那裡等待我們展示數據。

Got it. All right. Let me hop back into queue. Thank you for taking the questions.

知道了。好的。讓我重新回到隊列中。感謝您提出問題。

Thanks, Steve.

謝謝，史蒂夫。

Thank you so much. And your next question comes from the line of Kemp Dolliver from Brookline Capital Markets.

太感謝了。您的下一個問題來自 Brookline Capital Markets 的 Kemp Dolliver。

Hi. Good afternoon. And thank you for taking the question. First question regards the ASCEND trial. And admittedly, it may be too early to provide any insight on this. But the trial has enrolled very consistently and ahead of your original plan. And other than unmet need and potentially a great drug, which we'll just lay out as givens for now, what are your thoughts with regard to why this has worked so well?

你好。午安.感謝您提出問題。第一個問題涉及 ASCEND 試驗。誠然，現在對此提供任何見解可能還為時過早。但該試驗的入組情況非常一致，並且比您最初的計劃提前。除了未滿足的需求和潛在的偉大藥物（我們現在將其作為給定的）之外，您對為什麼這種藥物效果如此之好有何看法？

Is it a function of the populations in Australia and New Zealand being relatively treatment naive and there's less competition for trials? Or what have you seen going on that has worked to your benefit here?

這是因為澳洲和紐西蘭的人群對治療相對幼稚且試驗競爭較少嗎？還是你在這裡看到了什麼對你有利的事情？

Thanks, Kemp Appreciate that. I think we see a couple of factors that are helping the trial enroll very, very rapidly. First of all, it is a randomized and blinded trial. But in this particular trial, the people who receive the control arm are still receiving standard of care. So there's no downside to joining this trial.

謝謝，坎普很欣賞。我認為我們看到有幾個因素正在幫助試驗非常非常迅速地註冊。首先，這是一項隨機、盲法試驗。但在這次特殊的試驗中，接受控制臂的人仍在接受標準照護。所以參加這個試驗沒有什麼不好。

It's not as if you would be put on a true placebo and you would not get any treatment which would obviously be unethical in an oncology trial. I think you've already touched on one of the situations there. There seems to be a large and growing presence of pancreatic cancer in this part of the world. And there are relatively few treatment centers because the population of Australia is concentrated around the edges of the country.

這並不是說你會服用真正的安慰劑，並且不會得到任何治療，這在腫瘤學試驗中顯然是不道德的。我想你已經談到了其中一種情況。在世界這一地區，胰臟癌的發生率似乎很高，而且還在增加。由於澳洲的人口集中在該國的邊緣地區，因此治療中心相對較少。

The country is enormous. But as you all know, the interior is referred to as the outback because it's a desert-like area and there's really very little population. People are concentrated in areas, and they go to these larger centers pretty regularly. It's not as if there are many, many centers around the country for them to go. And so the people who are at those centers have been actively involved in the development of our trial of our drug from the beginning.

國幅員遼闊。但眾所周知，內陸地區之所以被稱為內陸地區，是因為那裡是類似沙漠的地區，人口確實很少。人們集中在一些地區，而且他們經常去這些較大的中心。全國各地並沒有很多很多的中心可供他們去。因此，這些中心的人員從一開始就積極參與我們藥物試驗的開發。

It was in Australia that the early Phase Ib, Phase IIa, very compellingly positive data were generated. And so there's an enthusiasm that I think is moving forward. And the fact that the addition of LSTA1 to standard of care doesn't seem to exacerbate the safety side effects of the standard of care is another reason why people are very eager to take on this particular trial.

正是在澳大利亞，產生了早期 Ib 期、IIa 期非常令人信服的正面數據。因此，我認為這種熱情正在不斷向前發展。事實上，將 LSTA1 添加到標準護理中似乎並沒有加劇標準護理的安全副作用，這是人們非常渴望參加這項特殊試驗的另一個原因。

So as you pointed out, it's enrolling very rapidly. Cohort A has been enrolled since the May-June timeframe. And we're about 95% of the way there. So the official projection is we'll be done by second quarter of next year. But I think anybody can do a quick extrapolation and recognize that it's likely to be done very, very much sooner than that.

正如您所指出的，它的招生速度非常快。 A 組自 5 月至 6 月期間開始註冊。我們已經完成了大約 95%。因此，官方預測我們將在明年第二季完成。但我認為任何人都可以快速推斷並認識到這可能會比這更快得多。

Right. Thank you. And just looking at your spending guidance, which honestly looks pretty level over the course of the runway period, how sensitive would that be to the ebb and flow of enrollment in your trials? Because you have Ascend wrapping up sooner than expected. It's probably one of your larger trials at this point. So how should we think about the correlation between those two things from here?

正確的。謝謝。只要看看你的支出指導，老實說，在跑道期間看起來相當水平，這對你的試驗中註冊人數的潮起潮落有多敏感？因為你的 Ascend 結束時間比預期早。這可能是您目前較大的試驗之一。那我們該如何思考這兩件事之間的相關性呢？

Well, like all trials, your spending is correlated. Except for startup at the beginning and closeout at the end, the steady state costs are per patient cost. So as you enroll, you incur expense. And then when you stop enrolling, you stop those types of expenses. But we also have to recognize that we have organized these trials, almost all of our trials, but ASCEND specifically, to be done.

嗯，就像所有的試驗一樣，你的支出是相關的。除了開始時的啟動和結束時的結束外，穩態成本是每個患者的成本。因此，當您註冊時，您會產生費用。然後當你停止註冊時，你就停止了這些類型的費用。但我們也必須認識到，我們已經組織了這些試驗，幾乎所有的試驗，但特別是 ASCEND 試驗，都需要完成。

First of all, in Australia, where the costs generally are lower than they might be in the United States. And where we get about 48% of all R&D dollars spent rebated back to us as cash at the end of the year. And also where we are essentially co-funding this trial if you will. I mean, we're providing the maximum amount of funding, but the number of the standard of cares from the hospitals are being funded by those hospitals.

首先，在澳大利亞，那裡的成本通常低於美國。到年底，我們將所有研發費用的約 48% 以現金形式回饋給我們。如果您願意的話，我們基本上也會共同資助這項試驗。我的意思是，我們提供了最大的資金，但醫院的護理標準數量是由這些醫院提供的。

There will be a reduction in expenditure relative to ASCEND once full enrollment is completed, but it may not be of the same magnitude that one might expect for a trial being completely funded by a sponsor here in the United States. But we still should see a reduction in costs associated with that.

一旦全部入組完成，相對於 ASCEND 的支出將會減少，但其幅度可能與人們預期的完全由美國申辦者資助的試驗不同。但我們仍然應該看到與之相關的成本下降。

Got it. And I'm assuming those rebates would show up as a contrary to the expense line as opposed to coming in on the top line. Is that right?

知道了。我假設這些回扣將顯示為與費用線相反，而不是進入頂線。是對的嗎？

I'll ask our head of finance. James, what's the accounting on the rebate?

我去問問我們的財務主管。詹姆斯，回饋的會計處理是怎樣的？

Yeah, that's correct. We do have four qualifying research and development activities in Australia. We are eligible to receive refundable tax incentives between 43.5% up to 48.5%. So that does largely offset, let's say, half of the expenses for the ASCEND study in Australia.

是的，這是正確的。我們在澳洲確實有四項合格的研發活動。我們有資格獲得 43.5% 至 48.5% 之間的可退還稅收折扣。因此，這確實在很大程度上抵消了澳洲 ASCEND 研究的一半費用。

And is that accounted for as a reduction in expense or as revenue?

這是作為費用減少還是作為收入來計算？

That is accounted for as a reduction in expense. So that would be a reduction to the R&D expense. So it's incorporated therein.

這被視為費用減少。因此，這將減少研發費用。所以它被納入其中。

Thank you for that.

謝謝你。

Thanks, kemp.

謝謝，坎普。

Thanks also for much on. Peter Enderlin from MAZ Capital.

也感謝您的大力支持。 MAZ Capital 的 Peter Enderlin。

Yes. My first question is a follow-up of an earlier one about the valuation of the stock. And that is, since LSTA1, seems to enhance the efficacy of a wide variety of oncology drugs and a variety of different modalities as well. The question is, have you guys experienced any inbound inquiries from bigger pharmas that are interested in collaborating with you?

是的。我的第一個問題是關於股票估值的早期問題的後續問題。也就是說，自 LSTA1 以來，似乎也增強了多種腫瘤藥物和多種不同治療方式的療效。問題是，你們是否曾經遇到有興趣與你們合作的大型製藥公司的入站詢問？

Hi, Peter. And thanks for the question. It actually gives me a chance to talk a bit about the business development activities. The simple answer to your question is yes. And I mentioned earlier the consummation of a lot of those, you know, potential deals is going to be based very, very much so on the delivery of the data that will come out over the course of these years.

嗨，彼得。謝謝你的提問。它實際上讓我有機會談論一下業務開發活動。你的問題的簡單答案是肯定的。我之前提到過，許多潛在交易的完成將非常非常依賴這些年來將出現的數據的交付。

I think, you know, all of these companies have products that, you know, do well by a variety of different definitions, but could clearly do better. And, you know, and the implication so far with the data that's been generated to date that LSTA1 can allow them all to do better.

我認為，你知道，所有這些公司都有的產品，你知道，從各種不同的定義來看，它們都做得很好，但顯然可以做得更好。而且，您知道，迄今為止產生的數據表明 LSTA1 可以讓他們做得更好。

And that should lead us to a number of possibilities for either exclusive or non-exclusive deals both on the R&D and the commercial side with, you know, a lot of players in the oncology world, or just simply the ability to market LSTA1 more broadly and have it utilized, you know, more broadly in the market when that time comes.

這應該會讓我們在研發和商業方面與腫瘤學領域的許多參與者達成獨家或非獨家交易的多種可能性，或者只是更廣泛地營銷 LSTA1 的能力到那時，你知道，它會在市場上得到更廣泛的利用。

But yes, we've had, you know, quite a lot of interest shown, and I think an expectation that that interest will continue to increase as data is generated.

但是，是的，我們已經表現出了相當多的興趣，而且我認為隨著數據的生成，這種興趣將繼續增加。

And if I can qualify that a little bit in terms of drilling down, do you see different levels of interest depending on, you know, the types of cancer or also since there are varying side effects in a lot of these treatments, does it vary somewhat by the type of modality like chemo, RNA, immunotherapy or whatever? Or is it pretty much across the board?

如果我可以稍微深入一點，你是否會看到不同程度的興趣，這取決於癌症的類型，或者因為許多治療方法都有不同的副作用，它是否會有所不同某種程度上取決於化療、RNA 、免疫療法等治療方式的類型？或者說它幾乎是全面的？

I would say it's reasonably distributed. The interest is reasonably distributed among people who are either developing new cytotoxics or are already marketing chemotherapeutics or immunotherapeutics. We've even had discussions with radiopharmaceutical companies, companies that have antisense products, even companies with cellular therapies and nanoparticles.

我想說的是它的分佈是合理的。這種興趣在正在開發新的細胞毒素或已經在行銷化療或免疫療法的人之間合理分配。我們甚至與放射性製藥公司、擁有反義產品的公司、甚至擁有細胞療法和奈米顆粒的公司進行了討論。

So I think there's a broad level of interest because the mechanism of action of LSTA1 in theory should help all of those better target solid tumors and infiltrate those tumors.

所以我認為人們很感興趣，因為從理論上講，LSTA1 的作用機制應該有助於所有這些更好地靶向實體瘤並滲透這些腫瘤。

And also reduce side effects, I guess, is an important part of it as well.

我想，減少副作用也是其中一個重要的部分。

I don't know if it'll reduce side effects. I want to be very careful what we say. That would be wonderful. But what we will say is that the evidence to date shows that list one will not increase the side effects of those agents.

不知道會不會減少副作用。我想非常小心我們所說的話。這樣就太好了。但我們要說的是，迄今為止的證據表明，清單一不會增加這些藥物的副作用。

So you should get better efficacy with the same level of side effects. Normally, to get better efficacy, you increase concentration. And that leads to greater side effects. So I think we're going to be able. But I wouldn't say that we eliminate side effects. We're not that far along yet.

因此，在相同水平的副作用下，您應該獲得更好的療效。通常，為了獲得更好的功效，您需要提高專注力。這會導致更大的副作用。所以我認為我們能夠做到。但我不會說我們消除了副作用。我們還沒那麼遠。

Thank you. And then just one quick one for Kristen. Did you mention the number or the percentage of enrollment so far in the BOLSTER trial? I didn't get it if you did.

謝謝。然後是克里斯汀的一個快速的。您是否提到了 BOLSTER 試驗迄今為止的入組人數或百分比？如果你明白的話我沒明白。

No, I did not. The BOLSTER trial recently opened and we're early in enrollment.

不，我沒有。 BOLSTER 試驗最近開始，我們正在早期註冊。

Okay. Thanks a lot. I'll get back in the queue. Thank you.

好的。多謝。我會回到隊列中。謝謝。

Thank you so much. (Operator Instructions) That concludes the question-and-answer session. I will now turn the call back to Dr. Mazzo for closing remarks.

太感謝了。 （操作員說明）問答環節到此結束。現在我將把電話轉回給馬佐博士做總結發言。

And again, thank you all for participating in today's call, and we look forward to speaking with you again during our next quarterly conference call and to continuing to provide updates on our achievements and progress. We remain grateful for your continued interest and support.

再次感謝大家參加今天的電話會議，我們期待在下一次季度電話會議期間再次與您交談，並繼續提供有關我們的成就和進展的最新資訊。我們仍然感謝您持續的關注和支持。