Lisata Therapeutics Inc (LSTA) 2022 Q2 法說會逐字稿

Welcome to the Caladrius Biosciences' Second Quarter 2022 Financial Results and Business Update Conference Call. (Operator Instructions) As a reminder, this call is being recorded today, Thursday, August 4, 2022.

歡迎參加 Caladrius Biosciences 2022 年第二季財務業績和業務更新電話會議。 （操作員指示）提醒一下，本次通話將於今天（2022 年 8 月 4 日，星期四）進行錄音。

I will now turn the call over to John Menditto, Vice President of Investor Relations and Corporate Communications at Caladrius. Please go ahead, sir.

現在我將電話轉給 Caladrius 投資者關係和企業傳播副總裁 John Menditto。先生，請繼續。

Thank you, operator, and good afternoon, everyone. Welcome to Caladrius' second quarter 2022 conference call to discuss our financial results and 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 Caladrius 2022 年第二季電話會議，討論我們的財務表現並提供業務更新。今天與我一起與我們一起的還有我們管理團隊的總裁兼首席執行官 David Mazzo 博士；研發執行副總裁兼首席醫療官 Kristen Buck 博士；以及財務和財政副總裁 James Nisco。

Shortly, before this call, we issued a press release announcing our second quarter 2022 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 you would like to be added to the company's email distribution list, please email me at jmenditto@caladrius.com.

在本次電話會議召開前不久，我們發布了一份新聞稿，宣布了我們 2022 年第二季度的財務業績，該新聞稿可在公司網站的“投資者和新聞”部分查閱，同時還提供本次電話會議的網絡直播重播。如果您尚未收到此新聞稿或希望加入公司的電子郵件分發列表，請發送電子郵件至 jmenditto@caladrius.com。

Before we begin, I will 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 Caladrius. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, with Form 10-K -- sorry, 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. Furthermore, the content of this conference call contains time sensitive iteration that is accurate only as of the date of this live broadcast, Thursday, August 4, 2022. Caladrius Biosciences undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.

在我們開始之前，我要提醒您，管理層在本次電話會議中發表的評論將包含前瞻性陳述，其中涉及有關 Caladrius 的營運和未來結果的風險和不確定性。我鼓勵您查看公司向美國證券交易委員會提交的文件，包括但不限於 10-K 表格（抱歉，是 10-Q、8-K 和 10-K），這些表格確定了可能導致實際結果或事件與前瞻性陳述中描述的結果或事件存在重大差異的具體風險因素。此外，本次電話會議的內容包含時間敏感的迭代，僅在本次直播之日（2022 年 8 月 4 日星期四）準確。 Caladrius Biosciences 不承擔修改或更新任何聲明以反映本次電話會議日期之後的事件或情況的義務。

With that, I will now turn the call over to Dr. Mazzo. Dave?

說完這些，我現在將電話轉給 Mazzo 博士。戴夫？

Thank you, John, and good afternoon, everyone, thank you for once again joining us today as we provide an overview of recent business highlights and discuss our second quarter 2022 financial results. I can say to you with much enthusiasm and certainty that 2022 is proving to be an outstanding year of progress for Caladrius as the proposed merger with Cend Therapeutics remains on track to close in the third quarter of this year, subject to approval by our stockholders. This transaction will be transformational for Caladrius creating upon closing a financially sound NASDAQ-listed company with a diverse product development pipeline, strong existing partnership and the potential for future attractive partnerships. The merged company will operate under the name Lisata Therapeutics, Lisata for short, and we'll focus on maximally exploiting the full potential of Cend's CendR Platform technology in a range of solid tumor indications while progressing Caladrius' current CD34-positive technology-based product candidates to their next development milestone.

謝謝你，約翰，大家下午好，感謝你們今天再次加入我們，我們將概述最近的業務亮點並討論我們 2022 年第二季度的財務業績。我可以非常熱情和肯定地告訴你們，2022 年對於 Caladrius 來說將是取得傑出進步的一年，因為與 Cend Therapeutics 的擬議合併仍有望在今年第三季度完成，但需獲得我們股東的批准。此次交易將對 Caladrius 產生重大變革，使其在納斯達克上市，成為一家財務狀況良好的公司，擁有多樣化的產品開發管道、強大的現有合作夥伴關係以及未來有吸引力的合作夥伴關係的潛力。合併後的公司將以 Lisata Therapeutics（簡稱 Lisata）的名義運營，我們將專注於最大限度地發揮 Cend 的 CendR 平台技術在一系列實體瘤適應症中的潛力，同時推動 Caladrius 目前基於 CD34 陽性技術的候選產品邁向下一個發展里程碑。

CEND-1, the lead product candidate from the CendR Platform has the potential to be combined with myriad of chemo and immunotherapeutic agents and could become an integral part of a revised standard of care therapy for many difficult to treat cancers. Coincident with the announcement of the signing of the definitive merger agreement back in April, we also announced that we had made a $10 million investment in Cend in order to maintain the momentum of development of CEND-1 and to allow for immediate collaboration between the companies. Since then, a number of achievements have been announced regarding CEND-1.

CEND-1 是 CendR 平台的主要候選產品，具有與多種化學和免疫療法藥物結合的潛力，並可能成為許多難治癌症修訂標準治療方案的一個組成部分。早在四月宣布簽署最終合併協議的同時，我們也宣布已向 Cend 投資 1000 萬美元，以保持 CEND-1 的發展勢頭，並促進兩家公司之間的立即合作。自那時起，CEND-1 已取得了許多成就。

For example, in June, it was announced that the first patient had been treated in the Phase IIb ASCEND study of CEND-1 in combination with gemcitabine and nab-paclitaxel for the treatment of first-line metastatic pancreatic ductal adenocarcinoma, mPDAC for short. This 125-patient study is a double-blind, randomized, placebo-controlled clinical trial being conducted at up to 40 sites in Australia and New Zealand, led by the Australasian Gastro-Intestinal Cancer Trials Group, in collaboration with the National Health and Medical Research Council's Clinical Trial Center at the University of Sydney.

例如，6月份宣布CEND-1合併吉西他濱和白蛋白結合型紫杉醇治療一線轉移性胰腺導管腺癌（簡稱mPDAC）的IIb期ASCEND研究已經完成首例患者治療。這項有 125 名患者參與的研究是一項雙盲、隨機、安慰劑對照的臨床試驗，在澳洲和紐西蘭的多達 40 個地點進行，由澳洲胃腸道癌症試驗組牽頭，與雪梨大學國家健康和醫學研究委員會臨床試驗中心合作進行。

Additionally, groundbreaking data was recently published in The Lancet Gastroenterology and Hepatology journal from the Phase Ib study of CEND-1 in combination with gemcitabine and nab-paclitaxel for the treatment of first-line mPDAC. The results reinforce our belief that CEND-1 could become a transformative new medicine for the treatment of pancreatic cancer and other difficult-to-treat solid tumors. Imminently, we expect to announce the collaboration with a major pharmaceutical company regarding CEND-1 as well as advancement of our plans to initiate a registration-worthy study of CEND-1 in mPDAC next year, along with the basket trial, exploring the advantages of combining CEND-1 with current standard of care in a variety of other solid tumor types.

此外，《柳葉刀胃腸病學和肝病學》雜誌最近發表了 CEND-1 聯合吉西他濱和白蛋白結合型紫杉醇治療一線 mPDAC 的 Ib 期研究的突破性數據。研究結果強化了我們的信念：CEND-1 可能成為治療胰臟癌和其他難治性實體瘤的變革性新藥。我們即將宣布與一家大型製藥公司就 CEND-1 展開合作，並推進明年在 mPDAC 中啟動 CEND-1 註冊研究的計劃，同時開展籃子試驗，探索將 CEND-1 與多種其他實體瘤類型的當前標準治療相結合的優勢。

With that, I will now turn the call over to James Nisco, our VP of Finance and Treasury, to review and provide commentary on our second quarter 2022 financial results. James?

現在，我將把電話轉給我們的財務和財務副總裁 James Nisco，以審查並評論我們 2022 年第二季的財務業績。詹姆斯？

Thanks, Dave. I'm pleased to join today to present a summary of our second quarter 2022 financial results. Starting with operating expenses. Research and development expenses for the 3 months ended June 30, 2022, were $3.2 million compared to $4.3 million for the 3 months ended June 30, 2021, representing a decrease of $1.1 million or 25%. This decrease was primarily due to a decrease in expenses associated with HONEDRA in Japan. Revenue received from the collaboration agreement and one-off recruiting expenses in the prior year.

謝謝，戴夫。我很高興今天能與大家一起總結我們的 2022 年第二季財務表現。從營運費用開始。截至 2022 年 6 月 30 日的 3 個月的研發費用為 320 萬美元，而截至 2021 年 6 月 30 日的 3 個月的研發費用為 430 萬美元，減少了 110 萬美元，降幅為 25%。這一下降主要是由於日本 HONEDRA 相關費用的減少。上一年合作協議所獲得的收入和一次性招募費用。

Research and development activities in the current year period focused on the advancement of our ischemic repair platform and related to execution of the FREEDOM trial, including preparation for an interim analysis and execution of the Phase Ib proof-of-concept trial of CLBS201 as a treatment for diabetic kidney disease, which commenced in the first quarter of 2022 with the first patient in the study treated in April 2022 and study closeout activities and preparation for the pre-consultation meetings with the Japanese Pharmaceuticals and Medical Devices Agency, or PMDA, and for HONEDRA in critical limb ischemia and Buerger's disease in Japan.

本年度的研究和開發活動集中於我們缺血性修復平台的進步以及與 FREEDOM 試驗的執行相關的活動，包括準備中期分析和執行 CLBS201 作為糖尿病腎病治療方法的 Ib 期概念驗證試驗，該試驗於 2022 年第一季度開始，研究中的第一位患者於 2022 年 4 月接受缺血性研究脈管炎患者使用 HONEDRA 進行預諮詢會議做準備。

General and administrative expenses, which focused on general corporate-related activities were $3.5 million for the 3 months ended June 30, 2022, compared to $2.8 million for the 3 months ended June 30, 2021, representing an increase of 24%. This increase was primarily due to onetime professional fees associated with the proposed merger with Cend Therapeutics. Overall, net losses were 6.6 and $5.7 million for the 3 months ended June 30, 2022 and June 30, 2021, respectively. As previously communicated, Caladrius made an investment of $10 million in Cend, in addition to entering into a collaboration agreement with Cend to maintain the development momentum of the Cend pipeline.

截至 2022 年 6 月 30 日的 3 個月，一般及行政費用（主要集中於一般公司相關活動）為 350 萬美元，而截至 2021 年 6 月 30 日的 3 個月為 280 萬美元，增長了 24%。這一增長主要歸因於與 Cend Therapeutics 擬議合併相關的一次性專業費用。整體而言，截至 2022 年 6 月 30 日和 2021 年 6 月 30 日的 3 個月的淨虧損分別為 660 萬美元和 570 萬美元。據先前透露，Caladrius 向 Cend 投資了 1000 萬美元，並與 Cend 達成合作協議，以保持 Cend 產品線的發展勢頭。

Turning now to our balance sheet and cash flow. As of June 30, 2022, the company had cash, cash equivalents and marketable securities of approximately $73 million, which is net of our $10 million investment in Cend and which we believe positions us well relative to the projected capital obligations for our existing development programs as well as our cash and investments balance target at the time of closing of the merger with Cend. That completes the financial overview.

現在來看看我們的資產負債表和現金流。截至 2022 年 6 月 30 日，公司擁有現金、現金等價物和有價證券約 7300 萬美元，扣除我們對 Cend 的 1000 萬美元投資後，我們認為，相對於我們現有開發計劃的預計資本義務以及與 Cend 合併完成時的現金和投資餘額目標，這使我們處於有利地位。財務概覽到此結束。

With that, I will now turn the call over to our Chief Medical Officer, Dr. Kristen Buck, for the review of our clinical development pipeline. Kristen?

現在，我將把電話轉給我們的首席醫療官克里斯汀·巴克博士，以審查我們的臨床開發流程。克里斯汀？

Thank you, James, and good afternoon, everyone. Before I provide an update on our current CD34 programs, I will reinforce what Dave had mentioned regarding our progress with Cend. Work under our collaboration agreement has been nothing short of seamless and the collaborative effort has already yielded great progress. We are excited about this opportunity and look forward to reporting more accomplishments in the coming weeks and months, including the final coalescence into a singular cohesive development team post-merger closing.

謝謝你，詹姆斯，大家下午好。在我提供有關我們目前 CD34 計劃的最新消息之前，我將重申 Dave 提到的有關我們與 Cend 合作的進展。我們的合作協議下的工作一直非常順利，合作努力也取得了巨大進展。我們對這個機會感到非常興奮，並期待在未來幾週和幾個月內報告更多成就，包括合併後最終合併成一個單一的、有凝聚力的開發團隊。

Turning to our current pipeline. As you know, Caladrius' current development portfolio features autologous cellular therapies designed to treat or reverse disease. Our belief is that curative cell therapy products when applied to the right indication can restore human health and potentially improve quality of life with a single administration as compared to a treatment that requires frequent re-administration.

轉向我們當前的管道。如您所知，Caladrius 目前的開發組合以旨在治療或逆轉疾病的自體細胞療法為特色。我們相信，與需要頻繁重新給藥的治療相比，治療性細胞療法產品如果應用於正確的適應症，只需一次給藥即可恢復人類健康並可能改善生活品質。

I will now provide a summary of progress and status for each of Caladrius' clinical programs. Kicking off with CLBS12, HONEDRA in Japan, our product candidate for the treatment of critical limb ischemia and Buerger's disease, HONEDRA was awarded a SAKIGAKE designation from the Japanese regulatory authorities for the treatment of critical limb ischemia and Buerger's disease, which is an orphan-sized subset of critical limb ischemia. The SAKIGAKE designation is akin to a regenerative medicine advanced therapy designation or an RMAT designation in the United States.

我現在將對 Caladrius 的每個臨床項目的進展和狀態進行總結。從 CLBS12 開始，我們的日本 HONEDRA 候選產品用於治療嚴重肢體缺血和血栓性血栓形成，HONEDRA 被日本監管機構授予 SAKIGAKE 稱號，用於治療嚴重肢體缺血和血栓性血栓形成，血栓性血栓形成是嚴重肢體缺血的一個孤兒病亞型。 SAKIGAKE 頭銜類似於美國的再生醫學先進療法稱號或 RMAT 稱號。

SAKIGAKE designation affords the recipient prioritized regulatory consultation, a dedicated review system to support the development and review process, including the option of a rolling registration submission as well as a reduced review time of 6 months for the registration application once filed. Additionally, under Japan's regenerative medicine legislation, products such as HONEDRA are eligible for early conditional approval and possibly full approval in Japan based on the assessment of the data from the trial or trials designed in direct collaboration with the Japanese Pharmaceuticals and Medical Devices Agency, PMDA.

SAKIGAKE 頭銜為獲得者提供了優先監管諮詢、支持開發和審查過程的專門審查系統，包括滾動註冊提交的選項以及註冊申請提交後 6 個月的縮短審查時間。此外，根據日本的再生醫學立法，根據與日本藥品和醫療器材管理局 (PMDA) 直接合作設計的試驗數據的評估，HONEDRA 等產品有資格在日本獲得早期有條件批准，甚至可能獲得完全批准。

Note that conditional approval of a regenerative medicine product only requires a demonstration of a trend toward a therapeutic effect, together with acceptable safety. Further, the SAKIGAKE designation is a highly sought regulatory classification in Japan. And we hope that this, coupled with positively trending data from our trial will make HONEDRA an attractive product for partnering to a Japanese pharmaceutical company. The company study of HONEDRA in Japan for the treatment of critical limb ischemia and burgers disease has shown positive results to date.

請注意，再生醫學產品的有條件批准僅需要證明其具有治療效果的趨勢以及可接受的安全性。此外，SAKIGAKE 頭銜在日本是備受追捧的監管分類。我們希望，這一點，加上我們試驗中呈現積極趨勢的數據，將使 HONEDRA 成為與日本製藥公司合作的有吸引力的產品。該公司在日本進行的HONEDRA用於治療嚴重肢體缺血和伯格斯病的研究迄今已顯示出積極成果。

The responses observed in the subjects who have reached an endpoint in this study are consistent with our expectations of therapeutic effect and safety based on previously published clinical trial data generated in Japan and the United States. However, as discussed in prior quarters, enrollment in the study was suspended due to the impact of the global COVID-19 pandemic on recruitment, especially in Japan, to minimize the operational and financial burden that we have incurred due to enrollment delays and lack of visibility on time to completion.

在本研究中達到終點的受試者中觀察到的反應與我們根據先前在日本和美國發布的臨床試驗數據對治療效果和安全性的預期一致。然而，正如前幾季所討論的那樣，由於全球 COVID-19 疫情對招募的影響（尤其是在日本），該研究的招募被暫停，以盡量減少因招募延遲和缺乏對完成時間的可見性而給我們帶來的運營和財務負擔。

Data from the follow-up of all patients completed in this registration-eligible clinical trial in Japan have been compiled and will be reviewed by the PMDA later this quarter. We are conducting an ongoing dialogue with the PMDA as to what needs to be considered in preparation for the formal consultation meetings, which preceded the Japanese new drug application. Simultaneously, the company is focusing its efforts on securing a Japanese partner to complete the remaining steps to produce registration in Japan.

在日本，此次符合註冊資格的臨床試驗中所有患者的追蹤數據均已匯總，並將於本季稍後由 PMDA 進行審查。我們正在與 PMDA 進行持續對話，討論在日本新藥申請之前的正式諮詢會議中需要考慮的事項。同時，該公司正致力於尋找日本合作夥伴，以完成在日本註冊的剩餘步驟。

Turning now to XOWNA or CLBS16 for the treatment of coronary microvascular dysfunction, or CMD. Coronary microvascular dysfunction is a disease that continues to be underdiagnosed and potentially afflicts millions annually, a vast majority of whom are female with no current treatment options. In May of 2020, Caladrius's announced the full data results from a Phase IIa ESCapE-CMD trial, showing a highly statistically significant improvement in coronary flow reserve correlating with symptom relief for patients with CMD after a single intracoronary injection of XOWNA. Subsequently, the company initiated a rigorous Phase IIb clinical trial known as the FREEDOM trial, which, to our knowledge, is the first controlled regenerative medicine trial in CMD in the United States. The FREEDOM trial is a double-blind, randomized, placebo-controlled trial designed to corroborate the results of the ESCaPE-CMD trial, while assessing the efficacy and safety of delivering autologous CD34 cells, our XOWNA product to subjects with CMD and without obstructive coronary artery disease.

現在轉向 XOWNA 或 CLBS16 治療冠狀動脈微血管功能障礙（CMD）。冠狀動脈微血管功能障礙是一種仍未被充分診斷​​的疾病，每年可能折磨數百萬人，其中絕大多數是女性，目前尚無治療選擇。 2020 年 5 月，Caladrius 公佈了 IIa 期 ESCapE-CMD 試驗的全部數據結果，結果顯示，在單次冠狀動脈內注射 XOWNA 後，CMD 患者的冠狀動脈血流儲備得到高度統計學上顯著改善，與症狀緩解相關。隨後，該公司啟動了一項嚴格的 IIb 期臨床試驗，即 FREEDOM 試驗，據我們所知，這是美國首個 CMD 領域的受控再生醫學試驗。 FREEDOM 試驗是一項雙盲、隨機、安慰劑對照試驗，旨在證實 ESCaPE-CMD 試驗的結果，同時評估向患有 CMD 且無阻塞性冠狀動脈疾病的受試者輸送自體 CD34 細胞（我們的 XOWNA 產品）的有效性和安全性。

As previously communicated, enrollment in the FREEDOM trial initially proceeded as planned with the first patient treated in January of 2021. However, the impact of the COVID-19 pandemic in the U.S. on patient and site availability, coupled with issues affecting all stages of the supply chain associated with patient qualification, product preparation and product administration, meet enrollment much slower than originally predicted and challenging to accelerate. Despite multiple protocol amendments to address these obstacles along with an increased number of sites in the study, the FREEDOM trial only had enrolled approximately 1/3 of the targeted 105 patients by May of this year. And at this rate, more than 4 years would likely have been required to reach the primary endpoint follow-up at 6 months post treatment for all subjects.

如前所述，FREEDOM 試驗的入組最初按計劃進行，第一位患者於 2021 年 1 月接受治療。然而，美國 COVID-19 疫情對患者和試驗地點可用性的影響，再加上影響與患者資格、產品準備和產品管理相關的供應鏈所有階段的問題，導致入組速度比最初預測的要慢得多，而且很難加速。儘管為了解決這些障礙對方案進行了多次修改，並且研究地點的數量也增加了，但截至今年 5 月，FREEDOM 試驗僅招募了目標 105 名患者的約 1/3。以這個速度，對於所有受試者，可能需要超過 4 年的時間才能達到治療後 6 個月的主要終點追蹤。

As a result, the company suspended further enrollment activities at that time and is in the process of conducting an interim analysis of the data to determine the next steps for the program, which may require a discussion with and guidance from the FDA. The company expects to have a decision on next steps for the program by the end of 2022.

因此，該公司當時暫停了進一步的招募活動，並且正在對數據進行中期分析，以確定該計劃的下一步行動，這可能需要與 FDA 進行討論並獲得其指導。該公司預計將在 2022 年底之前就該計劃的下一步做出決定。

Lastly, our most recently proposed development program, CLBS201 for the treatment of diabetic kidney disease, or DKD. The company initiated a Phase Ib open-label proof-of-concept trial evaluating CLBS201, a CD34-positive regenerative cell therapy investigational product for intrarenal artery administration in patients with diabetic kidney disease. This development program focuses on patients that exhibit rapidly progressing stage 3b/4 disease. The scientific rationale for the program is based on the association of progressive kidney disease with attrition of the microcirculation of the kidney.

最後，我們最近提出的開發計畫是 CLBS201，用於治療糖尿病腎病變（DKD）。該公司啟動了 Ib 期開放標籤概念驗證試驗，評估 CLBS201，這是一種用於糖尿病腎病變患者腎動脈內給藥的 CD34 陽性再生細胞治療研究產品。該開發計劃主要針對病情進展迅速的 3b/4 期患者。該計劃的科學原理是基於腎臟疾病的進展與腎臟微循環的損失之間的關聯。

Preclinical studies in kidney disease and injury models have demonstrated that protection or replenishment of the microcirculation results in improved kidney function. Our proof-of-concept protocol provided for a staggered sequentially dose cohort of 6 patients overseen by an independent Data Safety Monitoring Board with the objective of determining the tolerance of intrarenal cell therapy injection in diabetic kidney disease patients. As well as the ability of CLBS201 to regenerate kidney function. A key readout of data will occur at the 6-month follow-up visit for all patients.

腎臟疾病和損傷模型的臨床前研究表明，保護或補充微循環可改善腎功能。我們的概念驗證方案為 6 名患者提供了交錯順序劑量組，由獨立的資料安全監測委員會監督，目的是確定糖尿病腎病變患者對腎內細胞治療注射的耐受性。以及CLBS201再生腎功能的能力。所有患者在 6 個月的追蹤中都會讀取關鍵數據。

The first patient treated in this study of CLBS201 was in April of 2022, followed by completion of enrollment of all 6 subjects in July of 2022, as recently announced. We continue to anticipate top line data from all subjects by the first quarter of 2023. With that, I will now turn the call back to Dr. Mazzo. Dave?

CLBS201此項研究中治療的第一位患者於2022年4月開始，隨後於2022年7月完成全部6位受試者的入組，正如最近宣布的那樣。我們繼續預計到 2023 年第一季將獲得所有受試者的頂線數據。有了這些，我現在將電話轉回給 Mazzo 博士。戴夫？

Thanks, Kristen. While we continue to make progress on our current Caladrius programs, a tremendous amount of work already has been conducted under our collaboration agreement with Cend. Over the next month or so, we will be working diligently with Cend and with you, our shareholders, to finalize the merger transaction and look forward to announcing the closing by our target of the end of September of this year. As I hope you appreciate, we are tremendously excited about and motivated by the prospects that this merger will bring for patients, our employees and our shareholders, and we look forward to providing additional updates in the coming weeks and months.

謝謝，克里斯汀。在我們繼續推進目前的 Caladrius 專案的同時，我們與 Cend 的合作協議已經完成了大量的工作。在接下來的一個月左右的時間裡，我們將與 Cend 以及我們的股東密切合作，完成合併交易，並期待在今年 9 月底之前宣布完成交易。我希望您能理解，我們對此次合併將為患者、我們的員工和股東帶來的前景感到非常興奮和鼓舞，我們期待在未來幾週和幾個月內提供更多更新資訊。

And with that, operator, we're ready to take questions.

接線員，現在我們可以回答問題了。

(Operator Instructions) The first question comes from Kumar Raja with Brookline Capital.

（操作員指示）第一個問題來自 Brookline Capital 的 Kumar Raja。

So first, with regard to the ASCEND trial, what is the expectation in terms of how soon this 40 sites can come on board? And also, when do you think potentially enrollment could be completed in that trial? And in terms of the merger process, what remains to be done so that it can be consummated?

那麼首先，關於 ASCEND 試驗，預計這 40 個站點可以加入多久？另外，您認為該試驗什麼時候可以完成招募？就合併過程而言，還需要做哪些工作才能完成？

Thanks, Kumar. Appreciate your questions, and hope you're enjoying your summer. I'll take them in reverse order. So first, as far as the merger goes, things are working very well down the check list of activities that are required to consummate the legal transaction. What remains now is the final vote by shareholders of both companies and then the final legal transaction document signing that will occur once the shareholders approve the transaction. We collectively had filed the new proxy, the S-4 and a mailing of that document has gone out to all the Caladrius' shareholders. And beginning next week, we expect that shareholders will have the opportunity to begin to vote either online, by telephone or through the normal mail.

謝謝，庫馬爾。感謝您的提問，希望您度過一個愉快的夏天。我將按相反的順序來做。首先，就合併而言，完成法律交易所需的活動清單上的事情進展非常順利。現在剩下的就是兩家公司股東的最終投票，然後在股東批准交易後簽署最終的法律交易文件。我們共同提交了新的代理文件 S-4，並且該文件已郵寄給所有 Caladrius 股東。從下週開始，我們預計股東將有機會透過線上、電話或普通郵件進行投票。

And we hope that we will accumulate sufficient number of votes such that the voting will be completed, and we will announce an approval of all the resolutions at the currently scheduled special shareholder meeting for September 13. And then within 24 to 48 hours after that, assuming everything is approved, the legal documents will be completed, and we will be then officially Lisata Therapeutics trading under the ticker symbol LSTA on the NASDAQ.

我們希望能夠累積足夠的票數來完成投票，並在目前安排的9月13日特別股東大會上宣布批准所有決議。然後在24到48小時內，假設一切都獲得批准，法律文件將完成，然後我們將正式以Lisata Therapeutics的名稱在納斯達克以股票代碼LSTA進行交易。

Now going back to the ASCEND trial, the Phase IIb trial. This is a trial that's being run by the AGIGT -- I'm sorry AGITG in Australia. They just began enrolling patients just a month or so ago. And the expectation is that it will take probably a couple of years to complete enrollment. I don't have the specifics yet of when all 40 sites will be online. But we will expect to do our next conference call as Lisata Therapeutics. And at that point in time, not only will we have additional information and all the specifics about the CEND-1 programs, but we'll likely invite the CEO of Cend, who will be the President and CBO of Lisata to the call, and he'll be able to speak to some of these things as well.

現在回到 ASCEND 試驗，即 IIb 期試驗。這是由 AGITG 進行的一次試驗——抱歉，是澳洲的 AGITG。他們大約一個月前才開始招募病患。預計完成招生可能需要幾年時間。我目前還不清楚這 40 個站點何時能夠上線。但我們期望以 Lisata Therapeutics 的名義進行下一次電話會議。到那時，我們不僅會獲得有關 CEND-1 計劃的更多資訊和所有細節，而且我們可能會邀請 Cend 的執行長（他將擔任 Lisata 的總裁兼 CBO）參加電話會議，他也會談論其中的一些事情。

Finally, as a follow-up, you alluded about the pharmaceutical collaboration. Anything additional you can share about it.

最後，作為後續問題，您提到了製藥合作。您可以分享有關此內容的任何其他資訊。

The only thing, I can say is if everything goes well, watch the news wires for next week. That's all I can tell you.

我唯一能說的是，如果一切順利的話，請關注下週的新聞。這就是我能告訴你的全部。

(Operator Instructions) Our next question comes from Pete Enderlin with MAZ Partners.

（操作員指示）我們的下一個問題來自 MAZ Partners 的 Pete Enderlin。

On XOWNA, your commentary was that you expect a decision on the next steps by the end of this year. And my simple question is whose decision are we talking about? I know it's sort of a collaborative process, but are you saying the FDA makes a decision, you make a decision and then go to them? Whose are we really talking about as the initial decision maker in that situation?

關於 XOWNA，您的評論是，您預計今年年底將對下一步行動做出決定。我的簡單問題是，我們談論的是誰的決定？我知道這是一種協作過程，但您是說 FDA 做出決定，您再做出決定然後去找他們嗎？在這種情況下，我們真正在談論的是誰作為最初的決策者？

Pete, thanks for your question. In these kinds of situations, the FDA, the only types of decisions that FDA takes would be decisions related to safety and putting a company on clinical hold. Otherwise, it's up to the sponsor to take decisions about treating patients, conducting their trials and spending their money. The decision to which I refer is a decision that will be a Caladrius decision or if it occurs post-merger, it will be a Lisata decision, and it will be based upon an analysis of the data from the interim data analysis that's ongoing as well as any discussions that may be considered appropriate with the FDA. And so that's why we say we've given ourselves time to have those discussions with the agency should we need them. And that's why we projected having the answer by the end of the year, but it could come much sooner than that.

皮特，謝謝你的提問。在這種情況下，FDA 做出的唯一決定是與安全相關的決定以及暫停公司臨床研究的決定。否則，就由贊助商來決定如何治療患者、如何進行試驗、如何使用資金。我所指的決定是 Caladrius 的決定，或者如果是在合併後做出的，則是 Lisata 的決定，它將基於正在進行的中期數據分析以及與 FDA 進行的任何可能被認為適當的討論。這就是為什麼我們說我們給自己留出了時間，以便在需要時與該機構進行討論。這就是為什麼我們預計在今年年底前就能得到答案，但答案可能會來得更早。

Okay. And there was a comment about some revenues from the collaborative agreement with Cend. I mean I know you gave them $10 million, but what are we getting back must be fairly small because it was a factor in the reduction of R&D. But can you be a little more specific about that?

好的。還有一條評論涉及與 Cend 合作協議的一些收入。我的意思是，我知道你給了他們 1000 萬美元，但我們得到的回報一定很少，因為這是減少研發的因素。但能否更具體地說明一下呢？

I will. And this is really my apologies to James, our Vice President of Treasurer and to the Grant Thornton team, our auditors. But this is a bit of an accounting game, if you will. As part of the collaboration agreement, we have allocated resources from Caladrius to help work on the Cend programs. And until we are a single company, we are accumulating a set of charges for the time spent by Caladrius employees working on the Cend program at some sort of flat rate. So for the time being, those are being booked as a payable by Cend and a receivable by Caladrius, but also as part of the collaboration agreement as soon as the merger goes together and we combine the books from both companies that cancel each other out. So it's really not something that anybody should spend any time on.

我會。我在此向我們的財務副總裁詹姆斯和我們的審計師 Grant Thornton 團隊表示誠摯的歉意。但如果你願意的話，這有點像是會計遊戲。作為合作協議的一部分，我們已從 Caladrius 分配資源來協助 Cend 計畫。在我們成為一家公司之前，我們會以某種固定費率對 Caladrius 員工在 Cend 專案上花費的時間收取一定費用。因此，目前，這些款項被記為 Cend 的應付款項和 Caladrius 的應收款，但也作為合作協議的一部分，一旦合併完成，我們將合併兩家公司的帳簿，相互抵銷。所以這確實不是任何人應該花時間去做的事情。

Okay. And then the trial in Australia and New Zealand, is that because Cend had a historical relationship? Or is there some other specific reason to pick those particular venues?

好的。然後在澳洲和紐西蘭進行審判，是因為 Cend 有歷史關係嗎？或者選擇這些特定場地還有其他具體原因嗎？

Well, there are a couple of reasons why that venue was chosen, but this is a program that was initiated by Cend Therapeutics, and it's based upon existing relationships that they had in Australia, but also with a particular lead investigator who was able to procure additional funding to help support the further development in that geographic area. So that's why it's being done in Australia and New Zealand.

嗯，選擇該地點有幾個原因，但這是一個由 Cend Therapeutics 發起的項目，它基於他們在澳大利亞現有的關係，而且還有一位特定的首席研究員，他能夠獲得額外資金來幫助支持該地區的進一步發展。這就是澳洲和紐西蘭這樣做的原因。

Are there differences in how to work with the regulatory agencies over there? Are they easier to work with? Or is it similar? Or are there any other significant differences?

與那裡的監管機構合作的方式有什麼不同嗎？他們是否更容易合作？或者說類似？或是有其他顯著的差異嗎？

The Australian regulatory authorities have standards and practices that are similar to the FDA and the other Western European regulatory authorities. I think the main reason why people choose to work in that venue besides it being an interesting market for a product once it's ultimately approved, is that they -- the Australian government offers an R&D credit for work done in Australia that makes things financially attractive to do research there. And for some indications, they have a higher prevalence of disease, which makes recruitment a little bit easier as well.

澳洲監管機構的標準和實踐與 FDA 和其他西歐監管機構類似。我認為人們選擇在那裡工作的主要原因除了因為產品一旦最終獲得批准就會成為一個有趣的市場之外，還因為澳洲政府為在澳洲進行的研究提供研發信貸，這使得在那裡進行研究在經濟上具有吸引力。對於某些疾病來說，他們的發生率更高，這也使得招募變得更容易一些。

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

（操作員指示）問答環節到此結束。現在我將把電話轉回給 Mazzo 博士，請他作最後發言。

Again, thank you all for participating in today's call. We look forward to speaking with you again during our next quarterly conference call, which we expect will be conducted under the banner of Lisata Therapeutics to continuing to provide updates on our achievements and progress. We remain grateful for your continued interest and support. Stay well. Have a good evening, and enjoy the rest of your summer.

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，我們預計該會議將在 Lisata Therapeutics 的名義下進行，以繼續提供有關我們的成就和進展的最新資訊。我們仍然感謝您的持續關注和支持。保重。祝您有個愉快的夜晚，享受剩餘的夏天。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。