Aethlon Medical Inc (AEMD) 2025 Q4 法說會逐字稿

Good afternoon, and welcome to the Aethlon Medical fourth-quarter fiscal 2025 earnings and corporate update conference call. (Operator Instructions) Please note this event is being recorded.

下午好，歡迎參加 Aethlon Medical 2025 財年第四季財報及公司更新電話會議。（操作員指示）請注意，此事件正在被記錄。

I would now like to turn the conference over to Jim Frakes, Chief Officer and Chief Financial Officer. Please go ahead.

現在，我想將會議交給首席官兼首席財務官 Jim Frakes。請繼續。

Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's fiscal fourth-quarter 2025 earnings conference call. My name is Jim Frakes, and I am the Chief Executive Officer and Chief Financial Officer of Aethlon Medical.

謝謝接線員，大家下午好。歡迎參加 Aethlon Medical 2025 財年第四季財報電話會議。我叫 Jim Frakes，是 Aethlon Medical 的執行長兼財務長。

Now I have some bad news and some good news to report on this call. The bad news is since Dr. Steven LaRosa, our Chief Medical Officer, is out on a family vacation, you'll have to listen to my soliloquy throughout this call. But the good news is that we made more progress advancing in the clinic with our product this period than in any quarter since I've been with Aethlon.

現在，我有一些壞消息和一些好消息要在這次通話中報告。壞消息是，由於我們的首席醫療官 Steven LaRosa 博士正在外出度假，所以您只能聽我在整個通話過程中自言自語。但好消息是，我們本季在產品臨床方面取得的進展比我加入 Aethlon 以來的任何一個季度都要大。

At 4:15 PM Eastern Time today, Aethlon Medical released financial results for its fiscal fourth quarter ended March 31, 2025. If you have not seen or received Aethlon Medical's earnings release, please visit the Investors page at www.aethlonmedical.com to view it.

今天美國東部時間下午 4:15，Aethlon Medical 發布了截至 2025 年 3 月 31 日的第四季度財務業績。如果您尚未看到或收到 Aethlon Medical 的收益報告，請造訪 www.aethlonmedical.com 上的投資者頁面進行查看。

Following this introduction and the reading of the company's forward-looking statement disclaimer, I will provide an overview of our strategy and recent developments. I will then make some brief remarks on Aethlon's financials. We will then open up the call for the Q&A session.

在介紹完並閱讀了公司的前瞻性聲明免責聲明之後，我將概述我們的策略和最新發展。然後我將對 Aethlon 的財務狀況做一些簡短的評論。然後我們將開始問答環節。

Before we start the business portion of the call, please note that this news release -- 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.

在我們開始電話會議的業務部分之前，請注意，本新聞稿－今天的新聞稿和本次電話會議包含《1933 年證券法》（修訂版）和《1934 年證券交易法》（修訂版）所定義的前瞻性陳述。

The company cautions you that any statement that is not a statement of historical fact is a forward-looking statement. 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.

該公司提醒您，任何非歷史事實陳述都是前瞻性陳述。這些聲明是基於本次電話會議之日的預期和假設。此類前瞻性陳述具有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 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, 2025, 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, 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存在重大差異的因素，可在公司截至 2025 年 3 月 31 日的財政年度的 10-K 表年度報告、公司最新的 10-Q 表季度報告以及公司向美國證券交易委員會提交的其他文件中的“風險因素”標題下找到。除法律另有規定外，本公司無意也不承擔更新此資訊以反映未來事件或情況的任何義務。

With that, we will now cover the business portion update of this call. Let me start by highlighting some key developments from fiscal year-end 2025 through today. We treated the first three patients in our oncology trial using the Hemopurifier at clinical sites in Australia. We received regulatory approval in India to initiate a similar oncology study. We expanded our trial protocol to align with evolving standard of care in immunotherapy.

現在，我們將介紹本次電話會議的業務部分更新。首先，我來重點介紹從 2025 財年末到今天的一些關鍵發展。我們在澳洲的臨床點使用血液淨化器治療了腫瘤學試驗的前三名患者。我們已獲得印度監管部門的批准，可以進行類似的腫瘤學研究。我們擴展了試驗方案，以適應不斷發展的免疫療法護理標準。

Our preclinical data demonstrate 98.5% removal of platelet-derived extracellular vesicles or EVs in simulated Hemopurifier treatments. We're collaborating with University of California, San Francisco or UCSF on long COVID research with findings to be presented at the upcoming Keystone Symposium. And importantly, we significantly reduced our operating expenses through streamlined operations.

我們的臨床前數據表明，在模擬血液淨化器治療中，血小板衍生的細胞外囊泡或 EVs 被去除了 98.5%。我們正在與加州大學舊金山分校 (UCSF) 合作進行長期 COVID 研究，研究結果將在即將舉行的 Keystone 研討會上發表。重要的是，我們透過精簡營運大幅降低了營運費用。

Now let me go into more detail on a few of these items, starting with the progress in our cancer trial in Australia. We've completed Hemopurifier treatments in the first three participants enrolled in our safety, feasibility and dose-finding study of patients with solid tumors unresponsive to anti-PD-1 agents. Participant number one was treated at Royal Adelaide Hospital in January 2025, while participants two and three received treatment at Royal North Shore Hospital in Sydney in June 2025.

現在讓我更詳細地介紹其中的幾個項目，首先是我們在澳洲的癌症試驗的進展。我們已經在安全性、可行性和劑量探索研究中招募的前三名對抗 PD-1 藥物無反應的實體腫瘤患者完成了血液淨化器治療。參與者一號於 2025 年 1 月在皇家阿德萊德醫院接受治療，而參與者二號和三號於 2025 年 6 月在雪梨皇家北岸醫院接受治療。

Each participant received a single four-hour Hemopurifier treatment without device deficiencies or immediate complications and have now completed the prespecified seven-day safety follow-up. This milestone triggers the first meeting of an independent Data Safety Monitoring Board, or DSMB, which will review safety data and determine whether we can advance to the next treatment cohort.

每位參與者都接受了一次四小時的血液淨化器治療，沒有出現設備缺陷或直接併發症，並且已經完成了預先指定的七天安全追蹤。這一里程碑促使獨立資料安全監測委員會（DSMB）召開首次會議，該委員會將審查安全數據並確定我們是否可以進入下一組治療。

If we get the go-ahead, the next group of patients will receive two Hemopurifier treatments over the course of a one-week period. We expect to receive preliminary data from the first cohort in about three months. This will include insights into how the Hemopurifier affected EV levels and antitumor T cell activity.

如果我們獲得批准，下一組患者將在一周內接受兩次血液淨化器治療。我們預計將在大約三個月內收到第一批的初步數據。這將包括對血液淨化器如何影響 EV 水平和抗腫瘤 T 細胞活性的見解。

I, like all of you, I'm anxious to learn what the effects of our product are on EV removal and antitumor T cell activity from these cancer patients that were treated with our Hemopurifier.

我和大家一樣，急切地想知道我們的產品對接受血液淨化器治療的癌症患者的 EV 清除和抗腫瘤 T 細胞活性有何影響。

We also amended the trial protocol to allow enrollment of patients receiving combination therapies with either pembrolizumab better known as Keytruda or nivolumab marketed as Opdivo. That change reflects current treatment practices and should help us reach a broader patient pool.

我們也修改了試驗方案，允許招募接受 pembrolizumab（更廣為人知的名稱是 Keytruda）或 nivolumab（以 Opdivo 的名稱銷售）聯合療法的患者。這種變化反映了當前的治療實踐，並有助於我們涵蓋更廣泛的患者群體。

To put it in perspective, only about 30% of patients respond to these therapies long term. Tumor-derived EVs are thought to play a role in resistance to these treatments. The Hemopurifier is designed to bind and remove these EVs from the bloodstream, potentially improving the therapeutic response rates to anti-PD-1 antibodies.

從客觀角度來看，只有大約 30% 的患者對這些療法有長期反應。人們認為腫瘤衍生的 EVs 在抵抗這些治療方面發揮了作用。血液淨化器旨在結合並從血液中去除這些 EV，從而可能提高對抗 PD-1 抗體的治療反應率。

In our preclinical studies, we've already seen the Hemopurifier reduce the number of EV levels in plasma samples from cancer patients. But just to reiterate, the primary endpoint of this study is safety. We're monitoring for any adverse events and clinically significant changes in lab tests following the Hemopurifier treatments.

在我們的臨床前研究中，我們已經看到血液淨化器降低了癌症患者血漿樣本中的 EV 水平。但需要重申的是，這項研究的主要終點是安全性。我們正在監測血液淨化器治療後實驗室檢查中的任何不良事件和臨床顯著變化。

The study is designed to include between 9 to 18 participants and the patients will receive between one and three Hemopurifier treatments depending on the cohort. We are also conducting exploratory analysis to understand how the number of Hemopurifier treatments impact EV levels and whether lowering EVs might help improve the body's own natural ability to attack tumor cells. Those insights may help us shape the design of future clinical trials, including a potential premarket approval study.

該研究旨在納入 9 至 18 名參與者，患者將根據隊列接受一至三次血液淨化器治療。我們也正在進行探索性分析，以了解血液淨化器治療的次數如何影響 EV 水平，以及降低 EV 是否有助於提高人體自身攻擊腫瘤細胞的自然能力。這些見解可能有助於我們設計未來的臨床試驗，包括潛在的上市前核准研究。

Turning to activities in India. On June 19, we received formal approval from India's Central Drugs Standard Control Organization, or CDSCO, India's regulatory authority to begin a similar oncology study at Medanta Medicity Hospital. That approval followed a successful meeting with a Subject Expert Committee and prior Ethics Committee clearance. The trial will begin following a site initiation visit conducted by our India-based CRO, Qualtran.

談到印度的活動。6 月 19 日，我們獲得了印度中央藥品標準控制組織（CDSCO，印度監管機構）的正式批准，在 Medanta Medicity 醫院開始進行類似的腫瘤學研究。該批准是在與主題專家委員會成功會面並獲得倫理委員會批准之後做出的。試驗將在我們位於印度的 CRO Qualtran 進行現場啟動訪問後開始。

I'd also like to share a quick update from our research lab. On May 12, we published results of a preclinical ex vivo study in bioRxiv, and we have submitted a manuscript to a peer-reviewed journal for publication. In that study, we showed that the Hemopurifier using our proprietary GNA affinity resin removed 98.5% of platelet-derived extracellular vesicles or PD-EVs from human plasma during a timepoint equivalent to a four-hour Hemopurifier treatment.

我還想分享一下我們研究實驗室的最新進展。5 月 12 日，我們在 bioRxiv 上發表了一項臨床前體外研究的結果，並且已經將稿件提交給同行評審期刊發表。在該研究中，我們表明，使用我們專有的 GNA 親和樹脂的血液淨化器在相當於四小時血液淨化器治療的時間點內從人體血漿中去除了 98.5% 的血小板衍生的細胞外囊泡或 PD-EV。

Excessive levels of PD-EVs have been implicated in many serious conditions beyond cancer, including lupus, systemic sclerosis, multiple sclerosis, Alzheimer's disease, sepsis, and both acute and long COVID. These results reinforce the rationale behind our current oncology work and point to possible additional therapeutic applications in the future.

PD-EVs 水平過高與癌症以外的許多嚴重疾病有關，包括狼瘡、系統性硬化症、多發性硬化症、阿茲海默症、敗血症以及急性和長期 COVID。這些結果強化了我們目前腫瘤學工作的理論基礎，並指出了未來可能出現的更多治療應用。

Next, I'd like to make a few remarks about our scientific collaboration in long COVID research. Our collaboration with the UCSF Long COVID clinic has been accepted for a poster presentation at the Keystone Symposium on Long COVID this August, specifically August 10 through 13. The study analyzed blood samples from patients with long COVID and compared them to recovered individuals to evaluate the binding of larger and smaller EVs to our lectin affinity resin.

接下來，我想就我們在長期 COVID 研究方面的科學合作發表一些評論。我們與加州大學舊金山分校長期 COVID 診所的合作已被接受在今年 8 月的長期 COVID Keystone 研討會上進行海報展示，具體時間為 8 月 10 日至 13 日。該研究分析了長期 COVID 患者的血液樣本，並將其與康復者進行比較，以評估較大和較小的 EV 與我們的凝集素親和樹脂的結合。

These findings add to our growing body of evidence and support future exploration -- further exploration of the Hemopurifier in addressing the significant and still unmet medical need, impacting an estimated 44 million to 48 million people in the US, with an estimated economic burden in the billions in those with symptoms lasting for at least a year.

這些發現進一步豐富了我們不斷增長的證據，並支持未來的探索——進一步探索血液淨化器在解決重大且尚未滿足的醫療需求方面的作用，該疾病影響了美國約 4400 萬至 4800 萬人，對於那些症狀持續至少一年的人來說，估計會造成數十億美元的經濟負擔。

Finally, I want to highlight the work we did this past year to streamline our operations and significantly reduce our operating costs. This wasn't just about tightening the belt. It was about focusing our resources where they have the greatest clinical and regulatory impact.

最後，我想強調一下我們過去一年為精簡營運和大幅降低營運成本所做的工作。這不只是勒緊褲帶那麼簡單。這是為了將我們的資源集中在對臨床和監管影響最大的領域。

So in summary, I've worked at Aethlon Medical for a long time, and I've never seen this much forward progress in the clinic and in the lab since I joined the company. I'm very pleased with the progress.

總而言之，我在 Aethlon Medical 工作了很長一段時間，自從加入公司以來，我從未見過診所和實驗室取得如此大的進步。我對這項進展感到非常滿意。

Now let's touch briefly on the financials. As of March 31, 2025, we had a cash balance of approximately $5.5 million. Our operating expenses for the year came in at approximately $9.3 million. This was a reduction of approximately $3.3 million or 26% compared to the prior year. This decrease was largely due to lower payroll and related expenses as well as reductions in professional fees and general and administrative expenses.

現在讓我們簡單談談財務狀況。截至 2025 年 3 月 31 日，我們的現金餘額約為 550 萬美元。我們今年的營運費用約為 930 萬美元。與前一年相比，減少了約 330 萬美元，即 26%。這一下降主要是由於工資和相關費用的降低以及專業費用和一般及行政費用的減少。

We did record a noncash charge that impacted the income statement. Most notably, we recognized a $4.6 million noncash charge related to a warrant inducement offer that we made in March 2025. We raised approximately $2.3 million in cash through this warrant inducement offer. This involved temporarily lowering the exercise price of existing warrants and the issuance of new warrants.

我們確實記錄了影響損益表的非現金費用。最值得注意的是，我們確認了與我們在 2025 年 3 月提出的認股權證誘導要約相關的 460 萬美元非現金費用。我們透過該認股權證誘導要約籌集了約 230 萬美元現金。這涉及暫時降低現有認股權證的行使價格和發行新認股權證。

Because it was a noncash charge, it did not impact the net worth on our balance sheet. For those that wanted to take a deeper dive into the numbers, please refer to the earnings release that we just issued or the full 10-K annual report that we will issue following this call.

由於這是非現金費用，因此不會影響我們資產負債表上的淨值。對於那些想要深入了解這些數字的人，請參閱我們剛剛發布的收益報告或我們將在本次電話會議後發布的完整 10-K 年度報告。

Also, we recognized approximately $324,000 in other income related to the employee retention tax credit under the CARES Act and an additional $36,000 in related interest income from the IRS. The remaining expected credit was recorded as a receivable within current assets on our balance sheet. No such amounts were recorded in the prior fiscal year.

此外，我們也確認了與《關懷法案》下的員工保留稅收抵免相關的約 324,000 美元的其他收入，以及來自美國國稅局的額外 36,000 美元相關利息收入。剩餘預期信用被記錄為我們資產負債表中流動資產中的應收帳款。上一財政年度沒有記錄此類金額。

We included these earnings results and related commentary in our press release issued this afternoon. The release also included the balance sheet for March 31, 2025, and the statements of operations for the fiscal years ended March 31, 2025 and 2024.

我們在今天下午發布的新聞稿中包含了這些收益結果和相關評論。新聞稿還包括 2025 年 3 月 31 日的資產負債表以及截至 2025 年 3 月 31 日和 2024 年 3 月 31 日的財政年度的經營報表。

As I mentioned earlier, we will file our annual report on Form 10-K following this call. Our next earnings call for the fiscal first quarter ending June 30, 2025, will coincide with the filing of our quarterly report on Form 10-Q in August 2025.

正如我之前提到的，我們將在本次電話會議後提交 10-K 表格年度報告。我們下一次關於截至 2025 年 6 月 30 日的第一財季財報電話會議將與我們 2025 年 8 月提交 10-Q 表季度報告的時間一致。

And now I'd be happy to answer any questions that you may have. Operator, please open the call for questions.

現在我很樂意回答你們的任何問題。接線員，請打開電話詢問。

(Operator Instructions)

（操作員指示）

Marla Marin, Zacks.

瑪拉馬林，札克斯。

So there's a lot going on. Given that the company is involved now in conducting ongoing clinical study in Australia upcoming in India, the long COVID initiative, is it still right to think that the focus areas remain oncology, number one, followed by infectious disease or/long COVID and then potentially organ transplantation?

所以有很多事情發生。鑑於該公司目前正在澳洲進行一項臨床研究，即將在印度開展一項長期 COVID 計劃，那麼我們是否仍然認為重點領域仍然是腫瘤學，其次是傳染病或/長期 COVID，然後可能是器官移植？

Marla, this is Jim. Our focus remains almost entirely on oncology. The upcoming trial in India is virtually parallel to the Australian trial. So we already have Hemopurifier stationed at the hospital, the PI is an expert using the Hemopurifier. So that remains our primary focus. We took advantage of the relationship with UC San Francisco's Long COVID unit to obtain some precious but free samples that we analyzed once we were set up for the oncology trial. So that's a cost-effective area that's potentially very valuable, but it's early. We're going to present at that conference in August. And if there's a possible grant situation, we'll pursue that. But our main focus remains oncology.

瑪拉，這是吉姆。我們的重點幾乎全部集中在腫瘤學。即將在印度舉行的審判實際上與澳大利亞的審判同時進行。所以我們已經把血液淨化器部署在醫院，PI 是使用血液淨化器的專家。所以這仍然是我們關注的重點。我們利用與加州大學舊金山分校長期 COVID 部門的關係，獲得了一些珍貴但免費的樣本，並在腫瘤學試驗準備就緒後對其進行了分析。所以這是一個具有成本效益且潛在價值極高的領域，但現在還為時過早。我們將於八月在該會議上發表演講。如果存在可能的資助情況，我們就會尋求資助。但我們的主要關注點仍然是腫瘤學。

Okay. And when you say it's cost efficient, so there wasn't significant, if any, capital outlay in order to conduct the collaboration, and there is some potential for incoming nondilutive funds. Is that the right way to think about that?

好的。當您說它具有成本效益時，那麼進行合作所需的資本支出並不大（如果有的話），並且有可能獲得非稀釋性資金。這是正確的思考方式嗎？

If we can land such a nondilutive grant or contract with the government. It's still very early, Marla. We're presenting some early data. It looks interesting, but we would have a lot of work to do. So I don't want to overplay that. We were -- our history is in viruses. If there's another situation where we can help, we'll be poised to do that. But I don't want to understate how much we're focused on oncology. It remains our primary.

如果我們能夠與政府達成這種非稀釋性補助或合約。時間還很早，瑪拉。我們正在展示一些早期數據。它看起來很有趣，但我們還有很多工作要做。所以我不想誇大這一點。我們的歷史就是病毒的歷史。如果還有其他情況需要我們提供協助，我們也會盡力提供協助。但我不想低估我們對腫瘤學的關注程度。它仍然是我們的首要任務。

Right. Okay. And then one follow-up on that and then one other last question. So with the first three patients having been treated in Australia, could you please remind us again of -- and you might have already said this in your prepared remarks, if you did, I apologize, but could you remind us what the expected timeline is before you deliver some more robust data?

正確的。好的。然後對此進行一次跟進，然後是最後一個問題。因此，鑑於前三名患者已在澳洲接受治療，您能否再次提醒我們 - 您可能已經在準備好的發言中提到了這一點，如果您這樣做了，我很抱歉，但您能否在提供更可靠的數據之前提醒我們預期的時間表是什麼？

Well, once -- there's an electronic data equivalent of the clipboard that used to be on patients' beds in the old days. Once that is finalized and the PIs have signed off on it, they'll be presented to the Data Safety Monitoring Committee. There's a tentative meeting set up in July. If they like everything, they're going to give us a green light to proceed to the next cohort, which will be two treatments per week.

嗯，曾經有一次——有一個相當於剪貼簿的電子數據，以前放在病人的床上。一旦最終確定並獲得 PI 批准，它們將提交給資料安全監控委員會。七月將舉行一次暫定會議。如果他們覺得一切都滿意，他們就會批准我們進行下一批治療，每週進行兩次治療。

And at the same time, the blood samples that we've taken during the treatments and then afterwards have been sent by those hospitals to our lab at University of Sydney, and they'll measure the changes in EVs and T cells. And we expect to receive that data later on in the summer. As I mentioned in my remarks, I can't wait. I don't know what they'll be. Hopefully, good, but we've been waiting to see that kind of information for a long time as our shareholders.

同時，我們在治療期間和治療之後採集的血液樣本已由這些醫院送到我們位於雪梨大學的實驗室，他們將測量 EVs 和 T 細胞的變化。我們預計將在今年夏天晚些時候收到這些數據。正如我在評論中提到的，我等不及了。我不知道它們會是什麼。希望是好的，但作為我們的股東，我們已經等待看到這樣的訊息很久了。

Right. And then finally, my last question is, you talked about in the press release about some nonrecurring costs that were incurred in connection with the former -- some former executive. So should we be thinking that the nonrecurring expenses are for the time being are finished. We won't be seeing additional one-off costs?

正確的。最後，我的最後一個問題是，您在新聞稿中談到了與前任——一些前任高管相關的一些非經常性成本。那麼我們是否應該認為非經常性支出暫時已經結束了。我們不會看到額外的一次性成本嗎？

So we terminated three senior executives over like a year. And the former CEO, that ended -- there was a one-year payout for each of those. His ended in November of 2024. The second one ended -- will end on Monday, June 30, and the third will end in September. And I'm not anticipating -- I'm not expecting any more. I think it would probably be me or our Chief Science Officer. We're the only ones left with contracts like that. And I certainly hope that's not the case and don't expect it will be the case. So yeah, long-winded answer to your question, I'm not expecting more of that.

因此，我們在一年內解雇了三名高階主管。而前任執行長則結束了——每人都有一年的薪酬。他的任期於 2024 年 11 月結束。第二輪將於 6 月 30 日星期一結束，第三輪將於 9 月結束。我不再期待──我不再期待任何事了。我認為可能是我或我們的首席科學官。我們是唯一擁有此類合約的公司。我當然希望情況不會如此，也不期望情況會如此。是的，對於你的問題，我給了冗長的回答，我並不期待更多。

Swayampakula Ramakanth, H.C. Wainwright.

拉瑪坎特 (Swayampakula Ramakanth)，H.C. 溫賴特。

In terms -- first of all, congratulations on getting the third patient through the trial. So based on what I heard so far, it looks like as soon as you get the okay from the DSMB review, you potentially could be starting the second cohort sometime in August or something like that. So -- and does the amended protocol comes into effect for the second cohort, is it? So should we expect the enrollment, the next three patients -- the enrollment of the next three patients go much faster than the six-plus months that took for the first three? How should we think about that? And then after that cohort, is there another DSMB look for safety before you start the third cohort where I think it's three Hemopurifiers per week.

就此而言——首先，祝賀第三位患者通過試驗。因此，根據我目前聽到的消息，看起來一旦你獲得 DSMB 審查的批准，你就有可能在 8 月的某個時候開始第二批培訓。那麼——修改後的協議對第二批人員生效了嗎？那麼，我們是否應該預期接下來的三名患者的入組速度會比前三名患者的入組速度快得多（前三名患者入組耗時六個多月）。我們該如何看待這個問題？然後，在那批患者之後，在開始第三批患者之前，DSMB 是否會再次尋找安全性，我認為第三批患者每週需要三次血液淨化器。

So the first cohort that we believe we finished is one treatment per week, just one treatment only in one week. The second cohort will be two treatments in one week. And the third cohort will be three treatments in one week, Monday, Wednesday, Friday or Tuesday, Thursday, Saturday.

因此，我們認為我們完成的第一批治療是每週一次，一周僅進行一次治療。第二批將在一周內進行兩次治療。第三組為一週三次治療，週一、週三、週五或週二、週四、週六。

The DSMB will need to meet between each -- so the one next month about going to cohort number two. And then again, they'll need to meet before going to cohort number three to answer that question.

DSMB 需要在每次會議之間召開會議——因此下個月將召開一次會議討論第二批會議。然後，他們需要在進入第三組之前開會來回答這個問題。

In terms of recruitments, we now have three hospitals recruiting. The hospital that took the longest to get running because of it's larger and more bureaucratic is Genesis Healthcare in Sydney. And the population is just so much bigger in Sydney than Adelaide or Gold Coast. I think it's over 3 million people versus 1.2 million or 1.3 million in Adelaide. So many more potential patients, and we see weekly updates on recruiting and there's ongoing recruiting.

招募方面，我們現在有三家醫院在招募。由於規模較大且官僚主義較多，耗時最長的醫院是雪梨的 Genesis Healthcare。雪梨的人口比阿德萊德或黃金海岸多得多。我認為那裡的人口超過 300 萬，而阿德萊德的人口為 120 萬或 130 萬。潛在患者越來越多，我們每週都會看到招募更新，而且招募工作仍在持續進行中。

So we're -- we have a running start. We're not just waiting until the DSMB -- we're not going to treat anybody until they approved it, but we're trying to line up patients to quickly move into that. So there's a reason to think it should move much faster than the first cohort.

因此，我們已經有一個好的開始。我們不會只是等待 DSMB——在他們批准之前我們不會為任何人提供治療，但我們正在嘗試安排患者盡快接受治療。因此，我們有理由相信它的進展速度應該比第一批快得多。

Okay. And is there any potential for a third hospital to be joining in Australia? Or is it just these two hospitals are going to run the entire program?

好的。澳洲是否有可能出現第三家醫院加入？還是只有這兩家醫院將運作整個計畫？

Well, we have a third hospital in Gold Coast, which is north of Sydney, but they have not treated any patients yet. They could -- I mean they're still recruiting. I think it's a smaller hospital in a smaller population area. And we're looking at potential other hospitals. But again, we potentially only need six more patients, best case, three in each of the remaining two cohorts. So we have a running start. We're moving their screening. So there's reason to think it should go faster.

嗯，我們在雪梨北部的黃金海岸有第三家醫院，但他們還沒有治療任何病人。他們可以——我的意思是他們仍在招募。我認為這是人口較少地區的一家小型醫院。我們正在尋找其他潛在的醫院。但同樣，我們可能只需要另外六名患者，最好的情況是，剩下的兩個隊列中每個隊列需要三名患者。因此，我們已經有一個好的開始。我們正在轉移他們的放映時間。因此有理由認為它應該發展得更快。

Okay. And then switching geographies and going into India. So this is -- my understanding is it's just one hospital, Medanta. So what is the protocol there? Is the protocol there with a monotherapy or combination therapy because now that you know you have some safety in the first cohort, so could you just go straight into combination therapies there? Or what -- how is the protocol approved there?

好的。然後轉換地理位置並進入印度。所以這是——我的理解是它只是一家醫院，Medanta。那麼那裡的協議是什麼？該方案是採用單一療法還是聯合療法，因為現在您知道第一批患者有一定的安全性，那麼您能直接採用聯合療法嗎？或者——該協議在那裡是如何獲得批准的？

That's a good question. Right now, it's the original protocol as a monotherapy, and it was just approved. So that's something to think about. But the population -- that hospital is in Delhi. I don't know what the population is, but many millions of people. So -- and it's a very high-end private hospital. So I think their clientele should be able to afford these expensive drugs. I mean we don't pay for them, but it's not a small public hospital out in the countryside. It's a big hospital in a big city.

這是個好問題。目前，它是單一療法的原始方案，並且剛剛獲得批准。這是值得思考的事。但人口——那家醫院位於德里。我不知道人口有多少，但有數百萬。所以——這是一家非常高端的私立醫院。所以我認為他們的客戶應該可以負擔得起這些昂貴的藥物。我的意思是我們不為他們付錢，但這不是農村的小型公立醫院。這是大城市裡的大醫院。

Yes, I'm aware of it but --

是的，我知道，但是--

And the doctor that's in charge of the renal treatment side of the equation is very familiar with our technology. She's done many, many Hemopurifier treatments, albeit in hep C patients, not oncology patients. So they are comfortable with the device and the therapy.

負責腎臟治療的醫生非常熟悉我們的技術。她已經做過很多次血液淨化器治療，儘管是針對C型肝炎患者，而不是腫瘤患者。所以他們對該設備和療法感到滿意。

Okay. But it's going to be the same, right? So it will be three patients per cohort and --

好的。但一切都會一樣，對嗎？因此每組有三名患者，--

Yes, same. Exactly the same.

是的，一樣。一模一樣。

Okay. Okay. All right. And then the same thing includes there, too, like there's a DSMB look after every cohort similar to what you're doing in Australia. Is that -- or that's not true.

好的。好的。好的。然後同樣的事情也包括在那裡，就像你們在澳洲所做的那樣，DSMB 負責照顧每個群體。事實確實如此——或者事實並非如此。

Yes -- I believe that's true.

是的——我相信這是真的。

Okay. So now that at least you know you have both the geographies opened up, what are you thinking in terms of timing for this whole entire 9 or 18 patients that you want to test for this study to get done?

好的。那麼，現在您至少知道兩個地區都開放了，那麼您認為完成這項研究所需的全部 9 或 18 名患者的測試時間是怎樣的呢？

Well, if we assume one patient a month for the remaining six in Australia, that would take us out near calendar year-end. There would be data collection after that, writing up of reports, so another quarter or two. But in terms of Australia, I think we're looking at about 9 to 12 months to be completely done, including writing up the report. India, we'll just have to see how fast it goes. We're just getting going there.

好吧，如果我們假設澳洲剩餘的六名患者中每月有一名患者，那麼我們將在年底前出院。之後將會進行資料收集、撰寫報告，所以還需要一、兩個季度的時間。但就澳洲而言，我認為我們需要大約 9 到 12 個月的時間才能完成所有工作，包括撰寫報告。印度，我們只需看看它進展得有多快。我們正要去那裡。

Okay. So we should have a decent picture in a year from now, at least from the Australian side.

好的。因此，至少從澳洲方面來看，一年後我們應該會有一個清晰的認知。

I would think so. I would think so.

我認為是這樣。我認為是這樣。

Okay. All right. And then -- so with your current cash and with your current run rate, I mean the expense run rate, so what is the total run rate we could expect from this?

好的。好的。然後——那麼根據您當前的現金和當前的運行率，我的意思是費用運行率，那麼我們可以預期的總運行率是多少？

Well, like all small life science companies that doesn't have revenues, we will need to keep raising money until we can take government grants or partner with a larger company. So eventually, we will need to do more equity financing, which is why your firm and other investment banks would make a good business in the life science sector.

好吧，就像所有沒有收入的小型生命科學公司一樣，我們需要不斷籌集資金，直到我們能夠獲得政府補助或與更大的公司合作。因此，最終我們需要進行更多的股權融資，這就是為什麼貴公司和其他投資銀行能夠在生命科學領域取得良好表現的原因。

So in terms of getting a partner to the table, what sort of data do you think will help you get there?

那麼，就讓合作夥伴參與其中而言，您認為什麼樣的數據會對您有所幫助？

Well, hopefully, the data from this safety study will be sufficient to partner but only time will tell. I don't think we have enough -- we don't have any yet really. So it's all our hypothesis with a lot of safety data.

好吧，希望這項安全研究的數據足以為合作夥伴提供基礎，但只有時間才能證明。我認為我們還不夠——實際上我們還沒有足夠的。所以這都是我們基於大量安全資料的假設。

Anthony Vendetti, Maxim Group.

安東尼·文德蒂（Anthony Vendetti），馬克西姆集團（Maxim Group）。

Most of my questions have been answered. But maybe just following up because it was very recent that you received, I guess, June 19, the approval in India. Obviously, a large population there. I know you said about one a month in Australia. Do you think once that gets up and running, the opportunity to do more than one per month there exists? Or are you like, look, these are specialized patients shouldn't expect more than one per month?

我的大部分問題都已得到解答。但也許只是跟進，因為您最近才收到印度的批准，我猜是 6 月 19 日。顯然，那裡人口眾多。我知道您說過在澳洲大約一個月一次。您是否認為，一旦啟動並運行，就有機會每月做多件事？還是你會想，看，這些是專科病人，每個月的治療次數不應該超過一次？

It's very possible. We've observed the actual HP treatments in both Adelaide and Sydney, and they're basically held -- done in the dialysis suites without dialysis cartridges, our cartridge attached to a blood pumping machine. But the nurses seem comfortable with it from what we've seen we assume. So I don't think their ability to logistically treat the patients is a constraint. It's more of the patient recruitment. And if the oncologists begin to feel more comfortable, I would like to think more than one a month is possible. I can't. I mean I'll be happy if we can do one a month, but there's no reason why it couldn't be more.

這很有可能。我們觀察了阿德萊德和雪梨的實際 HP 治療情況，這些治療基本上是在透析室中進行的，沒有透析盒，我們的盒子連接到血液泵送機上。但從我們所看到的情況來看，我們推測護士們似乎對此感到滿意。所以我不認為他們在後勤上治療病人的能力是一個限制。這更多的是招募患者。如果腫瘤科醫師開始感到更舒服的話，我想一個月內進行一次以上的治療是可能的。我不能。我的意思是，如果我們每個月都可以做一次，我會很高興，但沒有理由不能做更多。

Yeah. Because I think -- I mean I think just comparing the populations, I think 10x the population in India versus Australia. So larger patient pool is what I was thinking and --

是的。因為我認為——我的意思是，我認為只要比較人口，印度的人口就是澳洲的 10 倍。所以我考慮的是擴大患者群體，--

Right. Right.

正確的。正確的。

Right. And then you mentioned one of the ways, obviously, equity financing, but grant money too. And I think you -- Aethlon has had grants before. I was wondering if you could just talk about the landscape for grant approval these days with all the changes going on at the government. Is getting grants approved, A, taking longer? Or B, is there just less grant money available and therefore, more difficult to get grant money at this point?

正確的。然後您提到其中一種方式，顯然是股權融資，但也有贈款。我認為 Aethlon 以前曾獲得過資助。我想知道您是否可以談談目前政府發生的所有變化以及撥款審批的情況。A，獲得撥款批准是否需要更長時間？或 B，目前可用的補助金是否較少，因此更難獲得補助金？

Well, we haven't had any experience with the HHS on the grant side of things since the regime change. I still get e-mails, ticklers from people in that business. So I know it is continuing. I mean I basically ran our DARPA. It was like a $6 million five-year contract. So I'm -- and we've had three or four smaller ones with HHS in the oncology area studying exosomes. They were small $300,000 grants.

嗯，自從政權更迭以來，我們在撥款方面還沒有與衛生與公共服務部有過任何合作經驗。我仍然會收到該行業人士發送的電子郵件和提示。所以我知道它還在繼續。我的意思是我基本上負責管理我們的 DARPA。這就像一份價值 600 萬美元的五年合約。因此，我們與衛生與公共服務部 (HHS) 合作，在腫瘤學領域進行了三到四個較小的外泌體研究。這些資助金額很小，為 30 萬美元。

So we are familiar with them. If we can find one that aligns with our goals, I'm 100% for it. But if it doesn't align with our goals, they're not really all that profitable. And I would think the -- with the current regime, the overhead rates that could be charged might be lower than -- based on what's happened with the universities' research overheads being cut. Not that that's really profit, but it's slimmer now than it was in those days. So we'll look. If we can find one that aligns, I think, would be fantastic.

所以我們對他們很熟悉。如果我們能找到一個符合我們目標的，我會 100% 支持。但如果它不符合我們的目標，那麼它們實際上就不會那麼有利可圖。我認為，在現行製度下，根據大學研究經費削減的情況，可以收取的管理費率可能會更低。這雖然不算真正的利潤，但比起當時來說，現在的利潤已經少很多了。所以我們會看看。如果我們能找到一個一致的，我想，那就太棒了。

Okay. And then just last question on the expense side. I know you've cut expenses a couple of times here. It seems like you're pretty much at -- I'm not going to say bare bones, but my guess is there's not much more to cut. What you have in terms of a staff is sort of what's necessary to continue to keep operating the company, correct?

好的。然後是關於費用的最後一個問題。我知道你已經在這裡削減了幾次開支。看起來你已經差不多了——我不會說只剩下骨架了，但我猜已經沒有什麼好削減的了。就員工而言，你們擁有的是維持公司運作所需的人員，對嗎？

I think that's a good insight. That is where we are. In fact, as activity ramps up with these oncology trials, expenses in the G&A area might go up a bit. But that's why I cut them back because I knew with success that would ramp up a bit.

我認為這是一個很好的見解。這就是我們現在的處境。事實上，隨著這些腫瘤學試驗活動的增多，G&A 領域的費用可能會略有增加。但這就是我削減它們的原因，因為我知道如果成功的話，它們的數量會增加。

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。我想將會議交還給 Jim Frakes 做最後發言。

I'd like to thank you all again for joining us today to discuss our fiscal fourth quarter results, and we look forward to keeping you up to date on future calls. Thank you again. Goodbye.

我想再次感謝大家今天加入我們討論我們的第四季度財務業績，我們期待在未來的電話會議上向大家通報最新情況。再次感謝您。再見。

The conference has 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。