Brainstorm Cell Therapeutics Inc (BCLI) 2024 Q2 法說會逐字稿

Greetings, and welcome to the Brainstorm Cell Therapeutics Second Quarter 2024 Conference Call. At this time, participants are in a listen-only mode. As a reminder, this call is being recorded.

您好，歡迎參加腦力激盪細胞療法 2024 年第二季電話會議。此時，參與者處於只聽模式。謹此提醒，此通話正在錄音中。

And I would now like to introduce your host for today's call, Michael Wood of LifeSci Advisors. Mr. Wood, you may begin.

現在我想介紹今天電話會議的主持人，LifeSci Advisors 的 Michael Wood。伍德先生，您可以開始了。

Good morning, everyone, and thank you for joining us today. Before passing it off to company management for prepared remarks, I would like to remind listeners that this conference call contains numerous statements, descriptions, forecasts, and projections regarding Brainstorm Cell Therapeutics and its potential future business operations and performance, statements regarding the market potential for the treatment of neurodegenerative disorders such as ALS, the sufficiency of the company's existing capital resources for continuing operations in 2024 and beyond, the safety and clinical effectiveness of the NurOwn Technology Platform, clinical trials of NurOwn and related clinical development programs and the company's ability to develop strategic collaborations and partnerships to support its business planning efforts.

大家早安，感謝您今天加入我們。在將其傳遞給公司管理層以供準備好的發言之前，我想提醒聽眾，本次電話會議包含有關Brainstorm Cell Therapeutics 及其未來潛在業務運營和業績的大量陳述、描述、預測和預測，以及有關市場潛力的陳述ALS 等神經退化性疾病的治療、公司現有資本資源是否足以在2024 年及以後持續運營、NurOwn 技術平台的安全性和臨床有效性、NurOwn 的臨床試驗和相關臨床開發項目以及公司的能力發展策略合作和夥伴關係以支持其業務規劃工作。

Forward-looking statements are subject to numerous risks and uncertainties, and many of these are beyond Brainstorm's control, including the risks and uncertainties described from time to time in the company's SEC filings. The company's results may differ materially from those projected on today's call, and the company undertakes no obligation to publicly update any forward-looking statements.

前瞻性陳述受到眾多風險和不確定性的影響，其中許多風險和不確定性超出了 Brainstorm 的控制範圍，包括該公司在 SEC 文件中不時描述的風險和不確定性。該公司的業績可能與今天電話會議中預測的結果有重大差異，該公司不承擔公開更新任何前瞻性聲明的義務。

Joining us on the call this morning will be Chaim Lebovits, President and CEO of Brainstorm and Alla Patlis, Interim Chief Financial Officer. In addition, Dr. Haro Hartounian, Chief Operating Officer; and Dr. Bob Dagher, Chief Medical Officer are also on the line and will be available to answer questions during the Q&A session.

今天早上參加我們電話會議的包括 Brainstorm 總裁兼執行長 Chaim Lebovits 和臨時財務長 Alla Patlis。此外，營運長 Haro Hartounian 博士；首席醫療官 Bob Dagher 博士也在線，並將在問答環節回答問題。

So I'd now like to turn the call over to Mr. Lebovits. Please go ahead.

現在我想把電話轉給萊博維茨先生。請繼續。

Hi. Thank you, Mike. Good morning and afternoon to everyone. Thank you for joining us today. We appreciate your continued interest and support in Brainstorm. We're making substantial progress in our preparations for the Phase 3b trial for NurOwn in ALS. Importantly, NurOwn is now a derisked asset having secured a written SPA agreement from the FDA. This significant milestone, which we announced earlier in the year, underscores the agency's recognition of the unmet need that exists in ALS.

你好。謝謝你，麥克。大家早安、下午好。感謝您今天加入我們。我們感謝您對腦力激盪的持續關注和支持。我們在 NurOwn 治療 ALS 的 3b 期試驗的準備工作中取得了實質進展。重要的是，NurOwn 現在已成為一項無風險資產，並已獲得 FDA 的書面 SPA 協議。我們在今年稍早宣布的這一重要里程碑強調了該機構對 ALS 中存在的未滿足需求的認識。

The FDA continues to be supportive and we are grateful for their input and advice. In addition to the FDA, during the second quarter, we reached alignment with FDA on CMC aspects of the Phase 3 trial. In June, we participated in a very constructive face-to-face Type C meeting and have now resolved previously outstanding CMC questions. Cell therapy products have certain additional complexities in the manufacturing process.

FDA 繼續提供支持，我們感謝他們的意見和建議。除了 FDA 之外，我們在第二季度也與 FDA 就 3 期試驗的 CMC 方面達成了一致。6 月份，我們參加了一次非常有建設性的面對面 CMC 會議，現在已經解決了先前懸而未決的 CMC 問題。細胞治療產品在製造過程中具有一定的額外複雜性。

Therefore, it's important that the FDA is involved at various steps during the regulatory process, including prior to initiating a pivotal trial. Our collaboration with the CRO has been instrumental in advancing key trial protocols. We have selected a leading CRO and are diligently building a network of over 12 leading clinical centers across diverse geographic regions to ensure broad patient access and representation. The manufacturing processes are well-advanced and I believe on track to meet production timelines. We remain committed to initiating the trial by the end of 2024 or the first quarter of 2025.

因此，FDA 參與監管過程中的各個步驟非常重要，包括在啟動關鍵試驗之前。我們與 CRO 的合作對於推進關鍵試驗方案發揮了重要作用。我們選擇了一家領先的 CRO，並正在努力建立一個由跨不同地理區域的超過 12 個領先臨床中心組成的網絡，以確保廣泛的患者訪問和代表性。製造流程非常先進，我相信能夠滿足生產時間表。我們仍致力於在 2024 年底或 2025 年第一季之前啟動試驗。

To bolster our financial position, we're actively pursuing non-dilutive funding, including a promising grant application with the potential to secure up to $15 million. ALS is a devastating disease with limited treatment options. The potential impact of a successful Phase 3b trial cannot be overstated. It could represent a significant breakthrough for patients and their families. We are committed to transparent communication and providing regular updates about our progress. We are grateful for the support and collaboration of the entire ALS community as we continue this important work.

為了鞏固我們的財務狀況，我們正在積極尋求非稀釋性資金，包括一項有前景的贈款申請，有可能獲得高達 1500 萬美元的資金。肌萎縮側索硬化症是一種毀滅性疾病，治療選擇有限。成功的 3b 期試驗的潛在影響怎麼強調都不為過。對於患者及其家人來說，這可能是一個重大突破。我們致力於透明的溝通並定期更新我們的進度。在我們繼續這項重要工作的過程中，我們感謝整個 ALS 社區的支持和合作。

I want to address the items in our proxy statement and the upcoming shareholder meeting. NASDAQ has notified us that we must maintain a $1 share price for 10 consecutive trading days by October 28 or risk delisting. Additionally, we need to achieve a $35 million market cap.

我想討論我們的委託書和即將召開的股東大會中的項目。納斯達克通知我們必須在10月28日之前連續10個交易日維持1美元的股價，否則將面臨退市風險。此外，我們需要達到 3500 萬美元的市值。

To address these challenges and provide the company with maximum flexibility, we've scheduled an earlier-than-usual annual shareholders meeting. A key item on the agenda is seeking shareholder approval to authorize the Board of Directors to affect the reverse tax split if deemed necessary to maintain our NASDAQ listing. It's important to understand that approving this proposal does not automatically trigger a risk fit.

為了應對這些挑戰並為公司提供最大的靈活性，我們安排了比平常更早的年度股東大會。議程上的一個關鍵項目是尋求股東批准，以授權董事會在認為有必要維持我們的納斯達克上市時影響反向稅收分割。重要的是要了解，批准此提案不會自動觸發風險調整。

It simply grants the Board the discretion to implement if it becomes necessary to comply with NASDAQ listing requirements. While we'll exhaust all possibilities to avoid a reverse split, including driving up the share price with good news, we believe it's essential to have this option available to protect shareholder value and maintain our NASDAQ listing.

它只是授予董事會在有必要遵守納斯達克上市要求時實施的酌處權。雖然我們將竭盡全力避免反向分拆，包括用好消息推高股價，但我們認為，有必要提供此選項以保護股東價值並維持我們在納斯達克的上市地位。

The Board will carefully consider all options, including a potential reverse split or transition to the OTCQB. If we opt for the OTCQB, we'll work diligently to regain NASDAQ compliance without resorting to a resplit. Our ultimate goal is to maximize shareholder value. We are confident in our ability to navigate these challenges and deliver value to shareholders. Your support in approving the proxy is crucial to ensuring we have the flexibility to make the best decisions for the company.

董事會將仔細考慮所有選項，包括潛在的反向分拆或過渡到 OTCQB。如果我們選擇 OTCQB，我們將努力重新獲得納斯達克合規性，而無需訴諸重新分拆。我們的最終目標是股東價值最大化。我們對應對這些挑戰並為股東創造價值的能力充滿信心。您對批准代理的支援對於確保我們能夠靈活地為公司做出最佳決策至關重要。

Thank you for your continued support. Alla?

感謝您一直以來的支持。阿拉？

Thank you, Chaim. Cash, cash equivalents and restricted cash were approximately $3.65 million as of June 30, 2024 compared to $0.75 million as of June 30, 2023. Research and development expenses for the three months ended June 30, 2024 and 2023 were approximately $0.9 million and $2.8 million respectively.

謝謝你，查姆。截至 2024 年 6 月 30 日，現金、現金等價物和限制性現金約為 365 萬美元，而截至 2023 年 6 月 30 日為 75 萬美元。截至2024年6月30日及2023年6月30日止三個月的研發費用分別約為90萬美元及280萬美元。

General and administrative expenses for the three months ended June 30, 2024 and 2023 were approximately $2 million and $2.7 million respectively. Net loss for the three months ended June 30, 2024, was approximately $2.5 million as compared to a net loss of approximately $5.3 million for the three months ended June 30, 2023. Net loss per share for the three months ended June 30, 2024 and 2023 was $4.13 respectively.

截至2024年6月30日及2023年6月30日止三個月的一般及行政費用分別約為200萬美元及270萬美元。截至2024年6月30日止三個月的淨虧損約為250萬美元，而截至2023年6月30日止三個月的淨虧損約為530萬美元。截至2024年6月30日及2023年6月30日止三個月的每股淨虧損分別為4.13美元。

I'll turn it back to Chaim to close the call.

我會將其轉回 Chaim 以結束通話。

Thank you so much, Alla. I'll now open the call for the written questions. Please, Mike, can you please go forward with the written questions?

非常感謝你，阿拉。我現在開始徵集書面問題。麥克，你能繼續提出書面問題嗎？

Yes. First question, can you please elaborate on the key milestones that investors should be looking forward to in the near term?

是的。第一個問題，您能否詳細說明投資者近期應該期待的關鍵里程碑？

Thank you, Mike. Absolutely, we're very enthusiastic about the potential catalysts that should drive significant shareholders value. In the near term, we are focused on several key milestones.

謝謝你，麥克。當然，我們對能夠推動顯著股東價值的潛在催化劑非常熱衷。短期內，我們將重點放在幾個關鍵里程碑。

Firstly, securing the first few trial side agreements is a crucial step. This demonstrates our ability to execute on the clinical trial timeline efficiently. Secondly, we're actively pursuing additional non-diluted funding through grants and strategic partnerships. Successful acquisition of these funds will significantly strengthen our financial position and accelerate our development timeline.

首先，獲得最初的幾項試驗協議是關鍵的一步。這證明了我們高效執行臨床試驗時間表的能力。其次，我們正在透過贈款和策略夥伴關係積極尋求額外的非稀釋資金。成功收購這些資金將顯著增強我們的財務狀況並加快我們的發展進度。

And of course, trial initiation and enrolling the first patient in the story are major milestones that will mark significant progress. We believe we can successfully execute on these milestones and deliver substantial value for our shareholders.

當然，試驗的啟動和招募第一位患者是重要的里程碑，將標誌著重大進展。我們相信我們能夠成功實現這些里程碑，並為我們的股東帶來巨大的價值。

Thank you. Next question. With the proposed increase in the authorized shares from 100 million to 250 million there's a possibility that existing shareholders would be significantly diluted. What is your plan for equity raises over the next several quarters?

謝謝。下一個問題。由於擬議將授權股份從 1 億股增加到 2.5 億股，現有股東的股權可能會大幅稀釋。您未來幾季的股權融資計畫是什麼？

Thank you for this question. Very good so we can clarify this. Of course, we understand the concern regarding potential dilution. What's important to emphasize, that an increase in authorized shares does not equate to immediate dilution. This action only provides us with the flexibility to pursue strategic opportunities without resorting to dilutive financing. Our primary focus is non-dilutive funding sources such as grants and other strategic collaborations. We have a successful track record of securing non-dilutive funding, demonstrating our ability to execute on this strategy.

謝謝你提出這個問題。非常好，我們可以澄清這一點。當然，我們理解對潛在稀釋的擔憂。需要強調的是，授權股份的增加並不等於立即稀釋。此舉僅為我們提供了尋求策略機會的彈性，而無需訴諸稀釋性融資。我們的主要重點是非稀釋性資金來源，例如贈款和其他策略合作。我們在獲得非稀釋資金方面擁有成功的記錄，這證明了我們執行這項策略的能力。

BCLI has a 15-year history of efficient capital management, issuing less than 100 million shares while raising close to $200 million. This demonstrates our commitment to maximizing shareholder value. The proposed increase in authorized shares is a strategic long term decision to ensure we have the flexibility to capitalize on future growth opportunities without unnecessary dilution. We will continue to explore all avenues to optimize capital allocation and minimize dilution.

BCLI 擁有 15 年高效資本管理的歷史，發行了不到 1 億股股票，籌集了近 2 億美元的資金。這體現了我們對股東價值最大化的承諾。擬議增加授權股份是一項策略性長期決策，旨在確保我們能夠靈活地利用未來的成長機會，而不會造成不必要的稀釋。我們將繼續探索各種途徑來優化資本配置並盡量減少稀釋。

Thanks, Chaim. And a related question, what non-equity funding sources currently have a good probability of transacting before initiation of the Phase 3b trial? Can you speak to grants, partnerships, or the potential outsourcing of intellectual property?

謝謝，柴姆。還有一個相關的問題，目前哪些非股權融資來源最有可能在 3b 期試驗啟動前進行交易？您能談談贈款、合作夥伴關係或潛在的智慧財產權外包嗎？

Thank you. So we're actively pursuing multiple non-equity funding revenues. Our previous grant award from CIRM, the California Institute for Regenerative Medicine was a good example of our efforts. It was a $16 million non-dilutive grant that supported our Phase 3 trial. We're also exploring partnerships with pharmaceutical companies and other industry stakeholders. These collaborations can provide both financial support and strategic advantages.

謝謝。因此，我們正在積極尋求多種非股權融資收入。我們之前從 CIRM（加州再生醫學研究所）獲得的資助就是我們努力的一個很好的例子。這是一筆 1600 萬美元的非稀釋性贈款，用於支持我們的第三階段試驗。我們也正在探索與製藥公司和其他行業利益相關者的合作夥伴關係。這些合作可以提供財務支援和策略優勢。

Outsourcing of intellectual property is not currently on the table. We believe that maintaining control over our core technology is essential for long-term success. However, we're open to strategic partnerships that involve technology sharing or licensing on the mutually beneficial terms. Thanks.

目前還沒有考慮智慧財產權外包。我們相信，維持對核心技術的控制對於長期成功至關重要。然而，我們對涉及技術共享或互利條件授權的策略合作夥伴關係持開放態度。謝謝。

The next question regarding the planned clinical trial. Is there a take a peak provision that would allow interim analysis of early signs of efficacy or reported?

下一個問題是關於計劃的臨床試驗。是否有採取高峰規定，允許對早期療效跡象進行中期分析或報告？

Thank you. So an independent Data Safety Monitoring Board is being established for the Phase 3b trial design. The Board members and their charter are currently under finalization but the DSMP will be responsible for periodic safety evaluations to monitor patients' safety and well-being. Thank you.

謝謝。因此，正在為第 3b 階段試驗設計建立一個獨立的資料安全監控委員會。董事會成員及其章程目前正在最終確定中，但 DSMP 將負責定期安全評估，以監測患者的安全和福祉。謝謝。

Next question, is the ALS FRS or at enrollment higher than in the prior Phase 3 study?

下一個問題是，ALS FRS 或入組時是否高於先前的第 3 階段研究？

Thanks. Bob, you want to take that question, please?

謝謝。鮑勃，你想回答這個問題嗎？

Yes. Thanks, Chaim. Based on properly conducted simulation, the total score of the ALS FRS is expected to be higher than in the previous trial and we're looking forward to executing the trial based on those assumptions. Thank you.

是的。謝謝，柴姆。根據正確進行的模擬，ALS FRS 的總分預計將高於先前的試驗，我們期待根據這些假設執行試驗。謝謝。

And also on the trial, will there be more trial sites than in the prior Phase 3, thus allowing the trial slots to be filled more quickly.

另外，在試驗中，試驗地點是否會比先前的第三階段更多，使試驗名額能夠更快地被填滿。

Thank you. That's for Bob too.

謝謝。這也是給鮑伯的。

Yeah, thanks. I'll take that question as well. Yeah, we are planning to add a higher number of sites for the Phase 3b trial than it was conducted in Phase 3 for the same, roughly number of patients, about 200 patients in the trial. We expect that this will increase the rate of enrollment and will also speed the timelines of the trial. Thank you.

是的，謝謝。我也來回答這個問題。是的，我們計劃為 3b 期試驗添加比第 3 期試驗更多的試驗點，試驗的患者數量大致相同，大約有 200 名患者。我們預計這將提高註冊率，並加快試驗進度。謝謝。

And has a commercial manufacturing partner being locked down at this point?

此時是否有商業製造夥伴被鎖定？

Haro, please take that one.

哈羅，請收下那個。

Thank you, Chaim, for the question. We're planning for multiple manufacturing sites for this trial and simultaneously are engaged in advanced discussions with highly qualified potential commercial manufacturing partners. While we cannot disclose specific detail until a contract is signed, we are confident in our ability to secure a suitable partner in a timely manner to support the commercial launch of our product if and when approved. Thank you.

謝謝查姆提出的問題。我們正在為此次試驗規劃多個生產基地，同時與高素質的潛在商業製造合作夥伴進行深入討論。雖然在簽署合約之前我們無法透露具體細節，但我們相信我們有能力及時找到合適的合作夥伴，以在獲得批准後支持我們產品的商業發布。謝謝。

Is the Phase 3b inclusion criteria more stringent than the prior Phase 3 study, thus ensuring a healthier pool of patients or trial participants?

3b 期納入標準是否比先前的 3 期研究更嚴格，從而確保患者或試驗參與者更健康？

Thank you. Bob, you want to take that?

謝謝。鮑勃，你想要那個嗎？

Yeah, sure. Thanks for the question as well. Yeah, we designed the inclusion criteria for the Phase 3b trial, being informed by the Phase 3, but they are more refined to focus on patients that are earlier in the disease in the course of their disease. The goal is to enroll patients with a higher likelihood of showing benefits from our treatment, which we believe will be also strengthened by having an overall robust data. Thank you.

是的，當然。也謝謝你的提問。是的，我們根據 3 期試驗的情況設計了 3b 期試驗的納入標準，但這些標準更加細化，以關注處於病程早期的患者。我們的目標是招募更有可能從我們的治療中獲益的患者，我們相信，透過全面可靠的數據，我們的治療效果也會得到加強。謝謝。

Thank you very much. I think that concludes the written questions we received. Ali, would you open the call for any additional questions from any investors on the line?

非常感謝。我認為我們收到的書面問題到此結束。Ali，您是否可以開始電話會議，詢問線上投資者的任何其他問題？

(Operator Instructions) Jason McCarthy, Maxim Group.

（操作員說明）Jason McCarthy，Maxim Group。

Hi. This is Joanne Lee on the call for Jason McCarthy. Thanks for taking the question and congratulations on the progress made this quarter. Just regarding the CMC alignment, does the company need to implement any new actions or adjustments on the CMC front to reach the alignment with the FDA?

你好。我是喬安妮李 (Joanne Lee)，為傑森麥卡錫 (Jason McCarthy) 通話。感謝您提出問題並祝賀本季的進展。就CMC一致性而言，公司是否需要在CMC方面實施任何新的行動或調整以與FDA達成一致？

Thank you very much. We did. We reached alignment to be able to initialize the trial. That was very important. Thank you for that clarifying question.

非常感謝。我們做到了。我們達成一致，以便能夠啟動試驗。這非常重要。謝謝你的澄清問題。

Got it. And just regarding the upcoming study, could you briefly remind us of the changes made to the ALS FRS entry criteria and how these adjustments may impact the upcoming Phase 3b? And just as a follow-up, if you could provide a mechanistic rationale for why an effect might be more easily identifiable under the new ALS FRS criteria?

知道了。關於即將進行的研究，您能否簡要提醒我們對 ALS FRS 准入標準所做的更改以及這些調整可能如何影響即將到來的 3b 階段？作為後續行動，您是否可以提供一個機械原理，說明為什麼在新的 ALS FRS 標準下，效果可能更容易識別？

Thank you. Bob, you want to take this question?

謝謝。鮑勃，你想回答這個問題嗎？

Sure. I'm happy to do that. Thank you for your question. So basically, there are a number of differences from the previous trial. The main criteria regarding to the ALS FRF is number one, to make sure that every item, the score is made up of 12 items. Every item on the score is scored at a 2, 3, or 4. Recall, each item can be scored from 0 to 4, 0 being the worst. So we are not allowing any 0 or any 1 enter on each one of the 12 items. That's number one.

當然。我很高興這樣做。謝謝你的提問。所以基本上，與之前的試驗有很多不同。ALS FRF 的主要標準是第一，確保每一項的分數由 12 項組成。分數上的每個項目的得分為 2、3 或 4。回想一下，每個項目的評分範圍為 0 到 4，0 表示最差。因此，我們不允許在 12 項中的每一項上輸入任何 0 或任何 1。這是第一名。

Number two, we are also not allowing the LS Total score to be either 45-40 not sorry, not 45. 46, or 47 or 48. 48 is the maximum, but once you start your first symptom, you drop from 48 typically to 47 or lower. The reason for that is we didn't want an allowance of the two years since first symptom for someone two years later to remain without really showing signs of progression by more than 1 or 2 points. So the score allows people to enter the trial at 45 or less.

第二，我們也不允許 LS 總分為 45-40，抱歉，不是 45。46，或 47 或 48。48 是最大值，但一旦您開始出現第一個症狀，您通常會從 48 下降到47或更低。原因是我們不希望兩年後的某人在首次出現症狀後的兩年內沒有真正表現出超過 1 或 2 個百分點的進展跡象。所以分數允許45分以下的人進入試用。

Number three, we are looking basically at associated entry criteria, such as a typical two-year term symptom onset, looking very carefully at first symptoms with a documented evidence of that and making sure that we get patients quickly after they get diagnosed with ALS. And we're also looking to get their respiratory function to be relatively stable, looking at low vital capacity to be above 65%, which is in the healthy side.

第三，我們基本上關注的是相關的准入標準，例如典型的兩年期症狀發作，非常仔細地觀察最初的症狀並有記錄的證據，並確保我們在患者被診斷患有ALS 後迅速找到他們。我們也希望他們的呼吸功能能相對穩定，低肺活量在65%以上，這是健康的一面。

Combining all of those together and simulating those entry criteria I mentioned on large databases, one of them is the ProAct database, we got a score, a total score that puts us at a confidence higher than what was conducted in the previous Phase 3 and in line with the modern ALS clinical trials that were conducted in recent years. So we have high confidence with these criteria together to get the population of target 4 that will benefit more from NurOwn, which is the population that's earlier in the disease 4. I hope this answers your question.

將所有這些結合在一起並在大型資料庫（其中之一是ProAct 資料庫）上模擬我提到的那些進入標準，我們得到了一個分數，總分使我們比之前的第3 階段和第3 階段中進行的信心更高。因此，我們對這些標準抱有很高的信心，使目標 4 的人群能夠從 NurOwn 中受益更多，即處於疾病 4 早期的人群。我希望這能回答你的問題。

Thank you so much, Bob.

非常感謝你，鮑伯。

Thank you for the questions.

謝謝你的提問。

Yeah. That was very helpful. Thanks again. Looking forward to further updates on the launch of the study. Thank you.

是的。這非常有幫助。再次感謝。期待有關該研究啟動的進一步更新。謝謝。

Thank you so much for being on the call today. Thank you.

非常感謝您今天接聽電話。謝謝。

David Bautz, Zacks Small-Cap Research.

David Bautz，Zacks 小型股研究公司。

Hey, good morning, everybody. So in regards to the upcoming Phase 3 trial, it looks like it's going to have a 24-week double-blind period and a 24-week open label extension. So in regards to potentially filing the BLA assuming positive results from the double-blind portion, could the BLA be filed essentially immediately after that or will the data from the open label extension be required for the BLA?

嘿，大家早安。因此，對於即將到來的 3 期試驗，看起來將有 24 週的雙盲期和 24 週的開放標籤延長。那麼，關於假設雙盲部分取得正面結果而可能提交 BLA，BLA 是否可以在此之後立即提交，或者 BLA 是否需要來自開放標籤擴展的資料？

No, we would be able to file the BLA after the first half of the double-blinded period. Thank you for that question.

不需要，我們可以在雙盲期前半段之後提交 BLA。謝謝你提出這個問題。

Okay. And I was wondering if you could comment just on the general sense of how patient advocacy groups, maybe even patients or physicians also their enthusiasm still for NurOwn and you've already commented about potentially seeking a non-dilutive funding, but I was going to ask about whether the patient efficacy groups would also potentially have any type of grants or funding available for the Phase 3 trial?

好的。我想知道您是否可以評論一下患者倡導團體、甚至患者或醫生對 NurOwn 的熱情仍然如何的一般感覺，您已經評論過可能尋求非稀釋性資金，但我打算詢問患者療效小組是否也可能為3 期試驗提供任何類型的補助金或資金？

Thank you very much for that question. We are working diligently with many patient advocacy groups and I can tell you that we're seeing even more excitement than the previous trial. Hopefully, we will see that publicly and also in ways of grants, but I can tell you across the board, patient efficacy are very supportive of this Phase 3b trial. As you know, some of them felt that we didn't have sufficient data in the Phase 3, but they're very supportive of the Phase 3b trial.

非常感謝你提出這個問題。我們正在與許多患者倡導團體努力合作，我可以告訴您，我們看到的結果比之前的試驗更令人興奮。希望我們能夠公開地以及以資助的方式看到這一點，但我可以全面地告訴你，患者的療效非常支持這項 3b 期試驗。如您所知，他們中的一些人認為我們在第 3 階段沒有足夠的數據，但他們非常支持第 3b 階段試驗。

They won't have an answer on NurOwn, a clear answer, and they think that the patient population that we are now focusing on, as Bob described again and again, is the patient population that has the best chance to show efficacy. So we're getting a lot of support and I think we are getting far stronger support from different groups that wasn't there in the past.

他們不會對 NurOwn 給出一個明確的答案，他們認為我們現在關注的患者群體，正如鮑勃一次又一次描述的那樣，是最有機會顯示療效的患者群體。因此，我們得到了很多支持，我認為我們從不同團體中得到了過去沒有的更強大的支持。

All right. Well, that's great to hear and thanks for taking the questions.

好的。嗯，很高興聽到這個消息，感謝您提出問題。

Yeah. Okay. Operator, we have time for one more question, please.

是的。好的。接線員，我們還有時間再問一個問題。

Understood, sir. We have a question from Christopher Nicholson, who is a private investor. Your line is live.

明白了，先生。我們有一位私人投資者克里斯托弗·尼科爾森 (Christopher Nicholson) 提出的問題。您的線路已上線。

Hi. Good morning, everybody. I'm not a private investor, I'm a research analyst at ACF Equity Research. I wondered if you are in a position to give any color on the cost of the trial at this point either on a per head basis or overall? And as a follow-up, are you able to give us any further color on the likely costs of production of each course of treatment at this time?

你好。大家早安。我不是私人投資者，我是 ACF Equity Research 的研究分析師。我想知道您是否能夠對目前的試驗成本（無論是按人均還是總體）進行說明？作為後續行動，您能否進一步說明目前每個療程的可能生產成本？

Thank you so much for these questions. So the answer is that we are still not in a position now. We will share, of course in the near future, more exact costs for the trial. The reason for that is that the main cost of the trial, the manufacturing costs, and we're still in the phase of finalizing contracts with different manufacturing centers from different geographies that will be different prices and it's not just a small difference. So therefore we're not able to.

非常感謝您提出這些問題。所以答案是我們現在還沒有處於一個位置。當然，我們將在不久的將來分享更準確的試驗費用。原因是試驗的主要成本，即製造成本，我們仍處於與來自不同地區的不同製造中心敲定合約的階段，這些成本將是不同的，而且不僅僅是一個小差異。所以我們不能這樣做。

The previous trial cost us about $50 million and with 200 patients only for 6 months and this time it's for 7 months, sorry, and this time it's for a longer period but we will provide numbers in a later stage and definitely not able to give you a reduction cost what it will be in a few years from now because the whole industry is changing with the CDMOs and also versus a manual process and maybe we'll be able to implement automatic process, which significantly would change prices to the product cost. We are really focused to try to bring down the product cost.

先前的試驗花費了我們大約5000萬美元，200名患者只進行了6個月，這次是7個月，抱歉，這次的時間更長，但我們會在稍後階段提供數字，絕對不能給你幾年後成本將會降低，因為整個產業正在隨著 CDMO 以及手動流程而變化，也許我們將能夠實施自動化流程，這將顯著改變產品成本的價格。我們確實致力於降低產品成本。

So while we are doing this huge undertaking of initiating this trial, we're still at the same time working very hard with R&D to get our processes cheaper as well. It's very important in gene and cell therapy, and we're very focused on that. But thank you very much for these questions.

因此，當我們正在進行這項試驗的艱鉅任務時，我們仍然在研發方面非常努力，以使我們的流程也更便宜。它在基因和細胞治療中非常重要，我們非常關注這一點。但非常感謝你提出這些問題。

Thank you. If I could just follow-up slightly on that one. Is it your experience that the current technological innovations that are going on in manufacturing and therapy development, Do they play well into your space? Is it the expectation that you could see costs reducing or is it somewhat the other way around because you're very innovative?

謝謝。如果我能稍微跟進一下就好了。根據您的經驗，目前在製造和治療開發方面正在進行的技術創新是否適合您的領域？是期望您能看到成本降低，還是因為您非常有創新精神而出現相反的情況？

Thank you very much for that question. So if we can get a validated automated product, definitely will be dramatically decreased. But even in the manual product, we are having many good developments to get the price cheaper. I think even in this trial, we may have a dramatic cheaper price per product than previously, hopefully, if you look on the whole thing. But we are still wearing out those exactly you're touching on things that we're working on now very hard and hopefully in the next quarters you will see different updates on this.

非常感謝你提出這個問題。所以如果我們能夠得到一個經過驗證的自動化產品，一定會大幅減少。但即使在手動產品中，我們也有許多良好的發展來降低價格。我認為，即使在這次試驗中，如果你縱觀整個事情，我們的每件產品的價格可能比以前便宜得多。但我們仍然在磨損那些你正在接觸的事情，我們現在正在非常努力地工作，希望在接下來的幾個季度你會看到這方面的不同更新。

Thank you very much indeed.

確實非常感謝。

Thank you very much. So I want to thank again everyone for being on the call today. We are finishing just on time for the 9:00 AM. We wanted to finish this call. Thank you very, very much for everyone joining us and thank you all for your continued support, and we're looking in the next quarter to have additional exciting updates in line to what we discussed today. We hope everything will fall in place and we'll be in a better place, when we speak in the next quarter, hopefully even after initiating a trial. Thank you very, very much.

非常感謝。因此，我要再次感謝大家今天參加電話會議。我們將於上午 9:00 準時結束。我們想結束這通通話。非常非常感謝大家加入我們，並感謝大家一直以來的支持，我們希望在下個季度有更多與我們今天討論的內容一致的令人興奮的更新。我們希望一切都會落實到位，當我們在下個季度發表講話時，我們會處於一個更好的位置，希望即使在啟動試驗之後也是如此。非常非常感謝。

Thank you, ladies and gentlemen. This does conclude today's conference call. You may disconnect your lines at this time and have a wonderful day. And we thank you for your participation.

謝謝你們，女士們、先生們。今天的電話會議到此結束。此時您可以斷開線路並度過美好的一天。我們感謝您的參與。