Aethlon Medical Inc (AEMD) 2025 Q2 法說會逐字稿

Good day and welcome to the Aethlon Medical fiscal second quarter 2025 earnings and corporate update. (Operator Instructions) Please note this event is being recorded.

美好的一天，歡迎來到 Aethlon Medical 2025 財年第二季財報和公司更新。（操作員說明）請注意此事件正在被記錄。

I would now like to turn the conference over to Michael Miller with Rx Communications. Please go ahead.

我現在想將會議轉交給 Rx Communications 的 Michael Miller。請繼續。

Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's fiscal second quarter 2025 earnings conference call. My name is Michael Miller with Rx Communications. At 4:15 PM Eastern Time today, Aethlon Medical released financial results for its fiscal second quarter ended September 30, 2024. If you have not seen or received Aethlon Medical's earnings release, please visit the Investors page at www.aethlonmedical.com to view it.

謝謝接線員，大家下午好。歡迎參加 Aethlon Medical 2025 財政年度第二季財報電話會議。我是 Rx Communications 的 Michael Miller。美國東部時間今天下午 4:15，Aethlon Medical 發布了截至 2024 年 9 月 30 日的第二財季財務業績。如果您尚未看到或收到 Aethlon Medical 的收益發布，請造訪 www.aethlonmedical.com 的投資者頁面查看。

Following this introduction and the reading of the company's forward-looking statement disclaimer, Aethlon's Chief Executive Officer and Chief Financial Officer, James Frakes; and Aethlon's Chief Medical Officer, Dr. Steven LaRosa will provide an overview of Aethlon's strategy and recent developments. Mr. Frakes will then make some brief remarks on Aethlon's financials. We will then open up the call for the Q&A session.

在閱讀完本介紹並閱讀公司的前瞻性聲明免責聲明後，Aethlon 執行長兼財務長 James Frakes 表示： Aethlon 首席醫療官 Steven LaRosa 博士將概述 Aethlon 的策略和最新發展。然後，Frakes 先生將對 Aethlon 的財務狀況發表一些簡短的評論。然後我們將開始問答環節。

Before I hand the call over to Mr. Frakes, please note that the news release today and this call contain forward-looking statements within the meaning of the Securities Act of 1933 as amended and the Securities Exchange Act of 1934 as amended. The company cautions you that any statement that is not a statement of historical fact is a forward-looking statement.

在我將電話轉交弗雷克斯先生之前，請注意今天的新聞稿和本次電話會議包含經修訂的 1933 年證券法和經修訂的 1934 年證券交易法含義內的前瞻性陳述。該公司提醒您，任何不是歷史事實陳述的陳述都是前瞻性陳述。

These statements are based on expectations and assumptions as of the date of this conference call. Such forward-looking statements are subject to significant risks and uncertainties, and actual results may differ materially from the results anticipated in the forward-looking statements.

這些陳述是基於截至本次電話會議之日的預期和假設。此類前瞻性陳述存在重大風險和不確定性，實際結果可能與前瞻性陳述中預期的結果有重大差異。

Factors that could cause the results to differ materially from those anticipated in forward-looking statements can be found under the caption Risk Factors in the company's annual report on Form 10-K for the fiscal year ended March 31, 2024, the company's most recent quarterly report on Form 10-Q and in the company's other filings with the Securities and Exchange Commission. Except as may be required by law, the company does not intend to nor does it undertake any duty to update this information to reflect future events or circumstances.

可能導致結果與前瞻性陳述中預期的結果有重大差異的因素可以在該公司截至2024 年3 月31 日的財年10-K 表格年度報告的“風險因素”標題下找到，該財年是該公司最新的季度報告10-Q 表和公司向美國證券交易委員會提交的其他文件中的報告。除非法律要求，否則公司不打算也不承擔任何義務更新此資訊以反映未來的事件或情況。

With that, I'll now turn the call over to Mr. James Frakes, Aethlon's Chief Executive Officer and Chief Financial Officer. Jim?

現在，我將電話轉給 Aethlon 執行長兼財務長 James Frakes 先生。吉姆？

Thank you, Mike, and I would like to thank all of you for dialing in. This is Jim Frakes. In October, as reported, Aethlon's Board of Directors appointed me to serve as the company's permanent Chief Executive Officer. I have served as Interim CEO since November 2023, and I look forward to continuing my role on a permanent basis.

謝謝你，麥克，我要感謝你們所有人撥通電話。這是吉姆·弗雷克斯。據報道，10 月份，Aethlon 董事會任命我擔任公司永久執行長。我自 2023 年 11 月起擔任臨時首席執行官，我期待永久繼續擔任我的職位。

As you know, Aethlon Medical is continuing the research and clinical development of its Hemopurifier, a blood, a therapeutic blood filtration system designed to bind and remove harmful exosomes and life-threatening viruses from blood and other biological fluids.

如您所知，Aethlon Medical 正在繼續其血液淨化器的研究和臨床開發，這是一種血液，一種治療性血液過濾系統，旨在結合併去除血液和其他生物液體中的有害外泌體和危及生命的病毒。

These qualities of the Hemopurifier have important potential applications in oncology, where cancer-associated exosomes may promote immune suppression and metastasis in life-threatening infectious diseases and in organ transplantation.

血液淨化器的這些特性在腫瘤學中具有重要的潛在應用，其中與癌症相關的外泌體可能促進危及生命的傳染病和器官移植中的免疫抑制和轉移。

As a reminder, the two goals that I stated were our key objectives when I was appointed Interim CEO were to move the company forward in oncology and to reduce our expenses in order to streamline operations.

提醒一下，當我被任命為臨時執行長時，我所說的兩個目標是我們的關鍵目標，一是推動公司在腫瘤學領域向前發展，二是減少開支以簡化營運。

As you will hear shortly, and as I'm happy to note, we made measurable progress on both of these fronts during the latest quarter and into the current period. Specifically, our emphasis on expense reductions has allowed for optimized resource allocation.

正如您很快就會聽到的那樣，我很高興地註意到，我們在最近一個季度和當前時期在這兩個方面都取得了可衡量的進展。具體來說，我們對費用削減的重視使得資源配置得到了最佳化。

This in turn, enabled our continued work on the high-impact area of oncology. And I'm very pleased to say that we advanced our oncology trial efforts in Australia during the latest quarter and into the current period. I'm gratified by this progress and expect that our shareholders will ultimately be rewarded by our efforts.

這反過來又使我們能夠繼續在高影響力的腫瘤學領域開展工作。我很高興地說，我們在最近一個季度和當前階段推進了在澳洲的腫瘤試驗工作。我對這一進展感到滿意，並期望我們的股東最終會因我們的努力而得到回報。

I will now turn the call over to Dr. LaRosa, who will give you an update on our oncology program to date, including one important milestone that we recently achieved and other potential upcoming milestones we expect to report later this calendar year.

我現在將把電話轉給拉羅薩博士，他將為您提供迄今為止我們腫瘤學計劃的最新情況，包括我們最近實現的一個重要里程碑以及我們預計在今年晚些時候報告的其他潛在的即將到來的里程碑。

Steve?

史蒂夫？

Thank you, Jim. First, I will discuss our Australian oncology study. As most of you have hopefully seen, earlier this week, we announced that the first patient was enrolled at the Royal Adelaide Hospital in Adelaide, Australia. And we are excited to update that now with the enrollment of a second patient from the same hospital.

謝謝你，吉姆。首先，我將討論我們的澳洲腫瘤學研究。正如你們大多數人所希望看到的那樣，本週早些時候，我們宣布第一位患者在澳洲阿德萊德皇家阿德萊德醫院入組。我們很高興地更新這一消息，現在來自同一家醫院的第二名患者已入組。

This marks a critical milestone for our oncology program and also constitutes great progress in the six months since we announced that we had pre-clinical data to support going forward with the clinical trial.

這標誌著我們的腫瘤學計畫的一個重要里程碑，也構成了自我們宣布擁有臨床前數據來支持臨床試驗進展以來的六個月以來的巨大進展。

Additionally, Pindara Private Hospital in Gold Coast, Australia is now open for patient enrollment and is actively screening for eligible subjects. Going forward, we expect to continue to enroll patients in this safety, feasibility and dose-finding trial of the Hemopurifier in patients with solid tumors who failed treatment with anti-PD-1 antibodies.

此外，澳洲黃金海岸的 Pindara 私立醫院現已開放病患登記，並正在積極篩選符合條件的受試者。展望未來，我們預計將繼續招募患者參加這項針對抗 PD-1 抗體治療失敗的實體腫瘤患者的血液淨化器安全性、可行性和劑量探索試驗。

Two observations would support this. One is we're seeing active prescreening logs from our sites, and we are heartened by the fact that patients as indicated by the two we've enrolled have thought the study interesting enough and important enough to go ahead and signed informed consent to be in the trial. We are awaiting full ethics board approval from a third Australian hospital located in Sydney.

有兩個觀察可以支持這一點。一是我們從我們的網站上看到了積極的預篩選日誌，我們感到振奮的是，我們招募的兩名患者表明，這項研究足夠有趣、足夠重要，可以繼續進行，並簽署了知情同意書。審判。我們正在等待位於雪梨的第三家澳洲醫院的道德委員會的全面批准。

The Aethlon team recently visited Australia between the October 9, and the October 19 of this year. On October 10, we had a site visit with the lab of Professor George Grau at the University of Sydney, who will be performing the central lab extracellular vesicle and T cell studies on samples from patients enrolled in the study.

Aethlon團隊最近於今年10月9日至19日訪問了澳洲。10 月 10 日，我們實地參觀了雪梨大學 George Grau 教授的實驗室，他將對參與研究的患者樣本進行中心實驗室的細胞外囊泡和 T 細胞研究。

On October 11, we had a highly interactive investigator meeting with members of all three Australian sites clinical research teams. This was then followed by individual site visits to all three clinical sites for training on the use of the Aethlon Hemopurifier.

10 月 11 日，我們與澳洲所有三個站點臨床研究團隊的成員舉行了一次高度互動的研究者會議。隨後，我們對所有三個臨床中心進行了單獨實地考察，接受 Aethlon 血液淨化器使用培訓。

Also in the second quarter, we received ethics committee approval from Medanta Medicity Hospital in India for a similar 9 to 18 patient safety, feasibility and dose-finding trial of the Hemopurifier. We have secured a clinical trial agreement with this site as well, and enrollment can proceed once we have regulatory approval for importing of the devices by the Central Drugs Standard Control Organization, known as the CDSCO.

同樣在第二季度，我們獲得了印度 Medanta Medicity 醫院倫理委員會的批准，對血液淨化器進行類似的 9 至 18 名患者的安全性、可行性和劑量探索試驗。我們也與該網站達成了臨床試驗協議，一旦我們獲得中央藥品標準控制組織（CDSCO）進口設備的監管批准，就可以進行註冊。

As a reminder, the primary endpoint of the approximate 9 to 18 patient safety, feasibility and dose-finding trial is safety. The trials will monitor adverse events and clinically significant changes in lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals after a two-month run-in period of the anti-PD-1 therapy, either Keytruda or Opdivo monotherapy.

提醒一下，大約 9 至 18 名患者的安全性、可行性和劑量探索試驗的主要終點是安全性。這些試驗將在接受抗PD-1 療法（Keytruda 或Keytruda）兩個月的磨合期後，在不同的治療間隔內監測血液淨化器治療的穩定或進展性疾病實體瘤患者的實驗室測試中的不良事件和臨床顯著變化。

Patients who don't respond to the anti-PD-1 antibody therapy will be eligible to enter the Hemopurifier phase of the study, where sequential cohorts will receive either one, two or three Hemopurifier treatments during a one-week period.

對抗 PD-1 抗體治療沒有反應的患者將有資格進入研究的血液淨化器階段，其中連續隊列將在一周內接受一次、兩次或三次血液淨化器治療。

In addition to monitoring for safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of extracellular vesicles and if those changes in EV concentrations improve the body's own natural ability to attack tumor cells.

除了監測安全性之外，研究還旨在檢查降低細胞外囊泡濃度所需的血液淨化器治療次數，以及 EV 濃度的這些變化是否會提高人體自身攻擊腫瘤細胞的自然能力。

These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety trial, including a pre-market approval known as a PMA study required by the FDA and other regulatory agencies.

這些探索性中心實驗室分析預計將為後續功效和安全性試驗的設計提供信息，包括 FDA 和其他監管機構要求的上市前批准（稱為 PMA 研究）。

Please note that currently, only approximately 30% to 40% of patients who receive the anti-PD-1 therapies, pembrolizumab or nivolumab will have a lasting clinical response to these agents. EVs produced by tumors have been implicated in the spread of cancers and the resistance of those agents -- to those agents, the anti-PD-1 therapies.

請注意，目前，接受抗 PD-1 療法、pembrolizumab 或 nivolumab 的患者中，只有約 30% 至 40% 會對這些藥物產生持久的臨床反應。腫瘤產生的 EV 與癌症的擴散和這些藥物（抗 PD-1 療法）的抗藥性有關。

The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve these therapeutic response rates to anti-PD-1 antibodies. In the preclinical studies I mentioned, the Hemopurifier has been shown to reduce the number of EVs in cancer patient plasma samples.

Aethlon 血液淨化器旨在結合並去除血液中的這些 EV，這可能會提高抗 PD-1 抗體的治療反應率。在我提到的臨床前研究中，血液淨化器已被證明可以減少癌症患者血漿樣本中的 EV 數量。

The company also continues to explore opportunities to expand the use of the Hemopurifier as a treatment for life-threatening viral infections. In vitro, it has shown effectiveness in binding a large library of envelope viruses, including those of recent concern, both domestically and internationally, including Marburg virus, Lassa virus, dengue, SARS-CoV-2 and H5N1 bird flu. That said, we believe that we stand poised to respond in the event of an epidemic or outbreak involving an envelope virus.

該公司也繼續探索擴大血液淨化器用途的機會，以治療危及生命的病毒感染。在體外，它顯示出與大量包膜病毒結合的有效性，包括最近國內外關注的病毒，包括馬堡病毒、拉沙病毒、登革熱、SARS-CoV-2和H5N1禽流感。也就是說，我們相信，一旦發生涉及包膜病毒的流行病或爆發，我們已做好應對準備。

With that, I'll turn the call back over to Jim for the financial discussion, and he will then open it up for questions.

這樣，我會將電話轉回給吉姆進行財務討論，然後他將開放提問。

Thanks, Steve, and good afternoon again, everyone. I will try to keep our financial overview brief with a focus on key points. For a more detailed analysis, you can refer to the financial statements attached to our earnings release that just hit the wire or in our soon to be filed quarterly report on Form 10-Q.

謝謝史蒂夫，大家下午好。我將盡量簡短地介紹我們的財務概況，並專注於重點。如需更詳細的分析，您可以參閱我們剛發布的收益報告所附的財務報表，或我們即將提交的 10-Q 表格季度報告中的財務報表。

As of September 30, 2024, Aethlon Medical held a cash balance of approximately $6.9 million. For the fiscal quarter ended September 30, 2024, our consolidated operating expenses were approximately $2.9 million, which was a decrease from $3.2 million in the same period of 2023.

截至2024年9月30日，Aethlon Medical持有現金餘額約690萬美元。截至 2024 年 9 月 30 日的財政季度，我們的綜合營運費用約為 290 萬美元，比 2023 年同期的 320 萬美元有所減少。

This decrease of approximately $300,000 or 9% in the 2024 period was primarily driven by a decrease of approximately $600,000 in professional fees that was partially offset by an increase of approximately $200,000 in payroll and related expenses and approximately $100,000 increase in general and administrative expenses.

2024 年期間減少約 30 萬美元或 9%，主要是由於專業費用減少約 60 萬美元，但部分被薪資和相關費用增加約 20 萬美元以及一般和管理費用增加約 10 萬美元所抵消。

The approximate $600,000 reduction in professional fees was mainly attributed to several factors, a $300,000 decrease in legal fees following a transition to a new legal firm, a $200,000 drop in contract labor expenses following the completion of projects with contract manufacturing organizations and R&D consultants and an $81,000 decline in accounting fees.

專業費用減少約 60 萬美元；與合約製造組織和研發顧問完成專案後，合約勞工費用減少了 20 萬美元；以及會計費用減少81,000 美元。

The approximate $200,000 increase in payroll and related expenses was largely driven by $500,000 in separation expenses, related to severance agreements following the termination of an executive and a workforce reduction.

薪資和相關費用增加約 20 萬美元，主要是由於 50 萬美元的離職費用，與解僱高階主管和裁員後的遣散協議有關。

However, this increase was partially offset by a $200,000 reduction in ongoing payroll expenses and a $100,000 decrease in stock-based compensation due to completed vesting and expiration of options associated with our reduced headcount.

然而，這一增長被持續工資支出減少 200,000 美元以及由於與我們減少的員工人數相關的期權完成歸屬和到期而導致股票薪酬減少 100,000 美元所部分抵消。

General and administrative expenses increased by $100,000, mainly due to a $163,000 increase in costs related to our ongoing oncology clinical trial that Steve just discussed. That increase was partially offset by a $33,000 reduction in supply expense following the completion of R&D projects, along with a combined $20,000 decrease related to conference and insurance expenses.

一般和行政費用增加了 100,000 美元，主要是由於史蒂夫剛才討論的正在進行的腫瘤臨床試驗相關成本增加了 163,000 美元。這一增長被研發項目完成後供應費用減少 33,000 美元以及與會議和保險費用相關的總計減少 20,000 美元所部分抵消。

As a result of the factors I just noted, our net loss decreased to approximately $2.8 million in the fiscal quarter ended September 30, 2024, from approximately $3 million in the same quarter of 2023.

由於我剛才提到的因素，我們的淨虧損從 2023 年同一季度的約 300 萬美元減少到截至 2024 年 9 月 30 日的財季的約 280 萬美元。

Now, I would like to note and emphasize that if we exclude the $500,000 provision related to an employee termination, our operating expenses decreased by approximately $700,000. We included these earnings results and related commentary in our press release issued this afternoon.

現在，我想指出並強調，如果我們排除與員工解僱相關的 50 萬美元準備金，我們的營運費用將減少約 70 萬美元。我們在今天下午發布的新聞稿中納入了這些盈利結果和相關評論。

The release also included the balance sheet for September 30, 2024, and the statements of operations for the three and six-month periods ended September 30, 2024, and 2023. We will file our quarterly report on Form 10-Q following this call. Our next earnings call for the fiscal third quarter ending December 31, 2024, will coincide with the filing of our quarterly report on Form 10-Q in February 2025.

新聞稿還包括2024年9月30日的資產負債表，以及截至2024年9月30日和2023年的三個月和六個月期間的營運報表。在本次電話會議之後，我們將提交 10-Q 表格的季度報告。我們的下一次財報電話會議將於 2024 年 12 月 31 日結束的第三財季召開，屆時我們將在 2025 年 2 月提交 10-Q 表格季度報告。

And now, Steve and I would be happy to take any questions that you may have. Operator, please open the call for questions.

現在，史蒂夫和我很樂意回答您可能提出的任何問題。接線員，請打開電話提問。

(Operator Instructions) Marla Marin, Zacks.

（操作員說明）Marla Marin，Zacks。

Thank you. Hi. So I have a few questions, if that's okay. I wanted to follow up on the launching initiating patient enrollment in the study in Australia, which is obviously really exciting now in terms of moving forward.

謝謝。你好。所以我有幾個問題，如果可以的話。我想跟進澳洲這項研究啟動患者入組的情況，這顯然是目前進展非常令人興奮的事情。

Okay. So since this is designed to be a basket study, are the first two patients who have been enrolled in the study representative of different solid tumor types?

好的。那麼，既然這是一項籃子研究，那麼最早入組的兩名患者是否代表了不同的實體瘤類型？

Yeah. Hi, Marla. Yeah, we're excited as well. So I'm glad to hear you're excited. Yes. So both of the patients have two of the tumor types that are described in the inclusion criteria. I don't want for the sake of patient privacy, I don't want to divulge a lot of clinical information about the patients. But yeah, they had two representative tumors for people who are treated with anti-PD-1 -- two different tumor types, yeah.

是的。嗨，瑪拉。是的，我們也很興奮。所以我很高興聽到你很興奮。是的。因此，這兩名患者都患有納入標準中描述的兩種腫瘤類型。我不想為了病人的隱私，不想洩漏很多病人的臨床資訊。但是，是的，對於接受抗 PD-1 治療的人來說，他們有兩種代表性的腫瘤——兩種不同的腫瘤類型，是的。

Got it. Okay. And then -- so I'm guessing that training the staff and the people who will be involved at the third location in Australia made sense to do because you were visiting Australia anyhow.

知道了。好的。然後 - 所以我猜對澳大利亞第三個地點的員工和人員進行培訓是有意義的，因為無論如何你都會訪問澳大利亞。

But is it reasonable to think that given that you put the time and effort into that training process that the company is highly confident that it will receive ethics committee approval at some point near term?

但是，考慮到您在培訓過程中投入了時間和精力，公司非常有信心在近期某個時候獲得道德委員會的批准，這樣的想法是否合理？

Yeah. The third site actually was able to piggyback on a prior ethics approval from another site since it's a central ethics committee board in Bellberry. So we already actually have the ethics -- a contingent ethics board approval. We have to add on the radiation assessment. So that's what's kind of adding on how much radiation people receive for X-rays has to be updated in there. So that's the only (inaudible)

是的。第三個站點實際上能夠利用另一個站點先前的道德批准，因為它是貝爾伯里的中央道德委員會委員會。所以我們其實已經有了道德規範──道德委員會的臨時批准。我們必須添加輻射評估。因此，這就是需要更新人們接受 X 射線輻射的數量。所以這是唯一的（聽不清楚）

So we have a lot of confidence that third site in Sydney will come up. Again, the nice thing is they've been trained. We actually went to the site and trained the nephrologist, and we were actually on a Zoom training call again last evening with the nephrologist. So we think they'll come up pretty quickly.

因此，我們對悉尼的第三個站點的出現充滿信心。再說一次，好的事情是他們接受過訓練。我們實際上去了現場並對腎病專家進行了培訓，昨晚我們實際上再次與腎臟病專家進行了 Zoom 培訓電話。所以我們認為它們會很快出現。

Can you explain to Marla and the shareholders why we're not giving them a dose (multiple speakers)

你能向瑪拉和股東解釋為什麼我們不給他們一劑嗎（多個發言者）

So what I mean by the radiation assessment is you have to get -- they want to -- what ethics boards want to know is how many X-rays do you need just for the sole purpose of being in the study. And for this, it's actually literally just a chest X-ray to confirm that your central venous catheter is in the right spot.

因此，我所說的輻射評估的意思是，你必須得到——他們想要得到——倫理委員會想要知道的是，僅僅為了參與研究的唯一目的，你需要多少次 X 光檢查。為此，實際上只是進行胸部 X 光檢查，以確認您的中心靜脈導管位於正確的位置。

So it's actually very minimal radiation that you receive for radiology just to be in this study. But it's -- again, it's a box that the ethics committees have to check.

因此，實際上，您參與這項研究時放射學所受到的輻射非常小。但這又是道德委員會必須檢查的一個框架。

Right. Okay. Got it. So it sounds like it's really just pretty pro forma at this point.

正確的。好的。知道了。所以聽起來現在這真的只是形式上的。

Yeah. So we think we're getting there with that third site. And again, they're going to be ready to hit the ground running because they've been trained.

是的。所以我們認為我們正在透過第三個站點實現這一目標。再說一次，他們將準備好立即投入使用，因為他們已經接受過培訓。

Right. Got it. Okay. And then lastly, can you just remind us of -- and Jim, I think this is probably more for you, but can you please remind us of what the whole rebate procedure is in Australia or maybe it's not referred to as a rebate, the 43% tax benefit that you're anticipating. Can you remind us of how the process works and what the timing on that will be?

正確的。知道了。好的。最後，您能否提醒我們 - 吉姆，我認為這可能更適合您，但是您能否提醒我們澳大利亞的整個退稅程序是什麼，或者也許它不被稱為退稅，您期望的 43% 稅收優惠。您能否提醒我們該流程如何運作以及具體時間是什麼？

Sure. And that is an important financial factor besides the very good medicine and excellent hospitals and principal investigators we're working with. So to spur the development of their life science industry, Australia has a 43% -- I believe, they call it a tax credit, but it's actually paid in cash, not as a tax credit as we would call it here in America.

當然。除了我們正在合作的非常好的藥物、優秀的醫院和主要研究人員之外，這是一個重要的財務因素。所以為了刺激他們的生命科學產業的發展，澳洲有43%——我相信，他們稱之為稅收抵免，但實際上是用現金支付的，而不是像我們在美國所說的稅收抵免。

So it's currently $0.43 on the [dollar]. So any dollar spent in Australia on the projects, one time a year, we can submit the data and then they cut a cheque thereafter once they go through the bureaucracy. So it's very attractive.

所以目前的價格是 0.43 美元[美元]。因此，在澳洲在這些項目上花費的任何美元，每年一次，我們都可以提交數據，然後一旦通過官僚機構，他們就會開支票。所以它非常有吸引力。

It comes close to cutting the cost in half. So we're just going through the submission now for the previous year. There wasn't much to submit because we were just getting going, but that should be important in future years.

它幾乎將成本削減一半。所以我們現在正在處理上一年的提交。沒有太多需要提交的內容，因為我們才剛開始，但這在未來幾年應該很重要。

And the central lab we're using is in Australia too. So we can apply that cost.

我們使用的中心實驗室也在澳洲。所以我們可以應用該成本。

Jeremy Pearlman, Maxim Group.

傑里米·皮爾曼（Jeremy Pearlman），馬克西姆集團。

Hi. Good afternoon. Thank you for taking my question. I'm actually on the line for Anthony Vendetti. Just two quick questions. Number one, see I always thought in the past that the trial for India was actually just going to be part of this trial in Australia, just a separate branch.

你好。午安.感謝您回答我的問題。我實際上是在接安東尼·文代蒂的電話。只是兩個簡單的問題。第一，我過去一直認為印度的試驗其實只是澳洲試驗的一部分，只是一個單獨的分支。

But now it seems reading the press release and on the call, it's a totally separate trial but has the same safety endpoint. So just could you maybe explain a little why the - why you felt it necessary to hold two trials with the same endpoint? Thanks.

但現在看來，閱讀新聞稿和電話會議時，這是一次完全獨立的試驗，但具有相同的安全性終點。那麼您能否解釋一下為什麼-為什麼您認為有必要進行兩次具有相同終點的試驗？謝謝。

Yeah. So when it comes to tumors as well as EV measurements and the population, there are differences in the genetics as well as in the comorbid illnesses between, say, a population in Australia and in India.

是的。因此，當涉及腫瘤、EV 測量值和人群時，例如澳大利亞和印度的人群之間在遺傳學以及共存疾病方面存在差異。

So we thought it was important to keep those as two discrete data sets and not comingle them where there could be some confounding if there are differences in patient populations. But the designs, as you say, are the same, but we thought it was important to keep the patient population data sets distinct.

因此，我們認為將它們保留為兩個離散的資料集非常重要，不要將它們混合在一起，因為如果患者群體存在差異，可能會出現一些混淆。但正如你所說，設計是相同的，但我們認為保持患者群體數據集的不同很重要。

Okay. Understood. And then going back to the trial in Australia. So you have two sites that are enrolling patients, and it seems like a third is really just around the corner. And now, you announced the first patient enrollment just a couple of days ago and now second. Do you have any more better visibility into when you think you'll conclude enrollment and when we could expect any data from the trial?

好的。明白了。然後回到澳洲的審判。因此，您有兩個正在招募患者的站點，並且似乎第三個站點即將到來。現在，您幾天前宣布了第一位患者入組，現在又宣布了第二位患者入組。您是否可以更好地了解您認為何時會完成註冊以及我們何時可以從試驗中獲得任何數據？

Right. So in terms of -- remember, this is -- it's designed as a sequential escalating cohort study where the first cohort gets one Hemopurifier treatment, the second cohort gets two and the third cohort gets three. There's supposed to be at least three completers in those three cohorts.

正確的。因此，記住，這是一項連續逐步升級的隊列研究，其中第一組接受一次血液淨化器治療，第二組接受兩次血液淨化器治療，第三組接受三次血液淨化器治療。這三個隊列中應該至少有三個完成者。

But to at least give you a sense of where we are right now. So as you said, we've enrolled two patients. They've gone through their screening activities. There's a number of tests that are done just to confirm that they're eligible after they sign consent and they have.

但至少讓你了解我們現在的處境。正如你所說，我們已經招募了兩位患者。他們已經完成了篩選活動。進行了許多測試，只是為了確認他們在簽署同意書後符合資格。

So they're in what's called the run-in period, which is a two-month period during which they're getting their anti-PD-1 therapy alone, and they're getting EV measurements, extracellular vesicle measurements and T-cell activity measurements.

因此，他們正處於所謂的磨合期，這是一個為期兩個月的時期，在此期間他們單獨接受抗 PD-1 治療，並且他們接受 EV 測量、細胞外囊泡測量和 T 細胞活動測量。

And at the end of those two months, if their imaging reveals that their tumor is not improving, if it's stable or progressive disease, then they would get the Hemopurifier treatment. So based on the two patients that we have currently, those people would presumably if they have stable or progressive disease, get dosed with the Hemopurifier in January.

在那兩個月結束時，如果他們的影像顯示他們的腫瘤沒有改善，如果疾病穩定或進展，那麼他們將接受血液淨化器治療。因此，根據我們目前擁有的兩名患者，如果這些人患有穩定或進展性疾病，他們可能會在一月接受血液淨化器治療。

Now that's when we get our first data in terms of safety, which again is the primary endpoint. That would be followed once the whole cohort is done. So I'm hoping there's more enrollment in the next -- in this month and next month.

現在我們得到了第一個安全性數據，這也是主要終點。一旦整個隊列完成，就會遵循這一點。所以我希望接下來——這個月和下個月——會有更多的報名者。

When we're done with the whole cohort, three months after that, we would actually have our first tranche of EV data and T cell data. So that would probably bring you out sometime into the summer of next year. So that would like you're going to get safety, you're going to get safety data first and then there's going to be EV and T cell data to follow. And that will be true as we progress to the other cohorts.

當我們完成整個隊列時，三個月後，我們實際上將獲得第一批 EV 數據和 T 細胞數據。所以這可能會讓你在明年夏天的某個時候出去。因此，如果您想要獲得安全性，您首先需要獲得安全數據，然後才是 EV 和 T 細胞數據。當我們進入其他隊列時，情況也會如此。

And we will report after we get the data for each cohort, Jeremy. We're not going to wait until the true end of the study.

傑里米，我們將在獲得每個隊列的數據後進行報告。我們不會等到研究真正結束。

Right. Understood. So is it also safe to say that because you have this two-month run-in period where you have to see if the patient responds to the anti-PD-1 treatment, so you might actually enroll more patients and then to play it safe because hopefully, some of them will respond and then for those who don't. So you'll have a larger pool to pull from?

正確的。明白了。那麼，這樣說是否也安全呢？希望他們中的一些人會做出回應，然後是那些沒有回應的人。那麼您將有一個更大的池可供使用？

That's right. So we're going to keep -- for each cohort, we're going to keep enrolling until we have sufficient numbers to complete those treatment cohorts with Hemopurifier. So you're right. If you estimate 70% of people don't improve, you're going to have to enroll probably a few more patients just to fill the cohort.

這是正確的。因此，對於每個隊列，我們將繼續招募，直到有足夠的人數來完成使用血液淨化器的治療隊列。所以你是對的。如果您估計 70% 的人沒有改善，您可能需要招募更多患者來填補隊列。

This concludes our question-and-answer session. I would like to turn the conference back over to Jim Frakes for any closing remarks.

我們的問答環節到此結束。我想將會議轉回吉姆·弗雷克斯（Jim Frakes）發表閉幕詞。

Thank you again for joining us today to discuss our fiscal second quarter results. We look forward to keeping you up to date on future calls. Goodbye.

再次感謝您今天加入我們討論我們第二季的業績。我們期待在未來的電話會議中為您提供最新資訊。再見。

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。