Aethlon Medical Inc (AEMD) 2026 Q4 法說會逐字稿

(audio in progress) and welcome to the Aethlon Medical fiscal year end March 31, 2026, financial results and corporate update conference call. (Operator Instructions) Please note this event is being recorded.

(音訊進行中) 歡迎參加 Aethlon Medical 截至 2026 年 3 月 31 日止財政年度的財務業績與公司最新進展電話會議。(接線員指示) 請注意，本活動將被錄音。

I would now like to turn the conference over to Jim Frakes, CEO and CFO of Aethlon Medical. Please go ahead.

現在我想把會議交給 Aethlon Medical 的執行長兼財務長 Jim Frakes。請開始。

Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's Fiscal Year-end March 31, 2026, Earnings Conference Call. My name is Jim Frakes, and I'm the Chief Executive Officer and Chief Financial Officer of Aethlon Medical. At 4:15 p.m. Eastern Time today, Aethlon Medical released financial results for its fiscal year ended March 31, 2026.

謝謝你，接線員，各位下午好。歡迎參加 Aethlon Medical 截至 2026 年 3 月 31 日止財政年度的財報電話會議。我叫 Jim Frakes，擔任 Aethlon Medical 的執行長兼財務長。今天美東時間下午 4:15，Aethlon Medical 已公布截至 2026 年 3 月 31 日止財政年度的財務結果。

If you have not seen or received Aethlon Medical's earnings release, please visit the Investors page at www.aethlonmedical.com to view it. Following this introduction and the reading of the company's forward-looking statement disclaimer, Dr. Steven LaRosa, our Chief Medical Officer, and I will provide an overview of Aethlon's 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.

若您尚未看到或收到 Aethlon Medical 的財報新聞稿，請造訪 www.aethlonmedical.com 的投資人頁面查閱。在本段開場與宣讀公司前瞻性聲明之免責聲明後，我與我們的首席醫療長 Steven LaRosa 醫師將概述 Aethlon 的策略與近期進展。接著我會就 Aethlon 的財務狀況做一些簡短說明。之後我們將開放問答環節。

Before we start the business portion of the call, 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. 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. 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, 2026, the company's most recent quarterly report on Form 10-Q and in the company's other filings with the Securities and Exchange Commission.

在我們開始本次電話會議的業務內容之前，請注意今日的新聞稿與本次電話會議包含《1933 年證券法》（修訂後）及《1934 年證券交易法》（修訂後）所定義的前瞻性聲明。公司提醒您，任何非歷史事實陳述的聲明均屬前瞻性聲明。這些聲明係基於本次電話會議當日的預期與假設。此類前瞻性聲明存在重大風險與不確定性，實際結果可能與前瞻性聲明所預期的結果有重大差異。可能導致結果與前瞻性聲明所預期者出現重大差異的因素，載於公司截至 2026 年 3 月 31 日止財政年度的 Form 10-K 年度報告、公司最近一期 Form 10-Q 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「風險因素」一節。

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. Now I would like to begin by highlighting progress during the fiscal year ended March 31 going on through the first part of June as we continue to execute against our strategy of advancing the Hemopurifier platform while maintaining disciplined cost control. During the period, we achieved important clinical research and intellectual property milestones. We continue to advance our oncology program while also expanding our evaluation of Hemopurifier applications into additional disease areas through preclinical research. These efforts reflect our broader objective of establishing the Hemopurifier as a platform technology with potential applications across multiple serious and life-threatening conditions.

除非法律另有要求，公司無意亦不承擔任何義務更新本資訊以反映未來事件或情況。現在我想先重點說明截至 3 月 31 日止財政年度期間，並延續至 6 月上旬的進展；我們持續執行策略，在維持嚴謹成本控管的同時推進 Hemopurifier 平台。在此期間，我們達成了重要的臨床研究與智慧財產里程碑。我們持續推進腫瘤學計畫，同時也透過臨床前研究，將 Hemopurifier 應用的評估擴展至更多疾病領域。這些努力反映我們更廣泛的目標：將 Hemopurifier 建立為一項平台技術，具備跨多種嚴重及危及生命病症的潛在應用。

Taken together, these achievements demonstrate continued execution against our key priorities of clinical development, platform expansion, intellectual property growth and disciplined resource management.

綜合而言，這些成果展現我們在臨床開發、平台擴展、智慧財產成長以及嚴謹資源管理等關鍵優先事項上的持續執行力。

And now, I will turn the call over to Dr. LaRosa, who will cover updates on the Australian oncology trial and on our R&D efforts. Steve?

接下來我將把電話交給 LaRosa 醫師，他將說明澳洲腫瘤試驗以及我們研發工作的最新進展。Steve？

Thank you, Jim. Enrollment and treatment of participants in Cohort 2 of our Australian oncology trial have been completed. As a reminder, 3 participants in Cohort 2 received two 4-hour Hemopurifier treatments during a 1-week treatment period. An independent data safety monitoring board reviewed the data, identified no safety concerns and recommended advancing to the third and final cohort of the study with no protocol modifications. Screening is actively underway at all 3 investigative sites for this final cohort where 3 to 6 participants will be treated with 3 Hemopurifier sessions during a 1-week period.

謝謝你，Jim。我們澳洲腫瘤試驗第 2 組（Cohort 2）的受試者招募與治療已完成。提醒各位，第 2 組的 3 位受試者在 1 週治療期間接受了兩次、每次 4 小時的 Hemopurifier 治療。獨立資料安全監測委員會審查了資料，未發現任何安全疑慮，並建議在不修改試驗方案的情況下推進至研究的第三組也是最後一組。目前在全部 3 個研究中心正積極進行此最後一組的篩選；該組將治療 3 至 6 位受試者，於 1 週期間接受 3 次 Hemopurifier 治療。

The first participant in Cohort 3 of the study has been enrolled and received 3 Hemopurifier treatments without any device deficiencies or immediate complications and is now in the safety follow-up period. Serial extracellular vesicle and T cell measurements on participants in Cohort 2 have been measured by the central lab at the University of Sydney. Formal statistical analyses comparing the effects of the 3 different Hemopurifier dosing regimens on these parameters will be performed by our CRO at the completion of the trial. As a reminder, this is a 9- to 18-patient study designed to evaluate the safety and the feasibility of the Hemopurifier treatments and determine an appropriate dosing interval in participants with solid tumors whose disease is stable or progressing while on a treatment that includes anti-PD-1 agents, KEYTRUDA or Opdivo. Segueing now to our preclinical activities.

本研究第 3 組（Cohort 3）的第一位受試者已完成入組，並在未出現任何裝置缺陷或即時併發症的情況下接受了 3 次 Hemopurifier 治療，目前正處於安全性追蹤期。第 2 組受試者的連續性細胞外囊泡（extracellular vesicle）與 T 細胞測量，已由雪梨大學的中央實驗室完成檢測。在試驗完成後，我們的 CRO 將進行正式統計分析，比較 3 種不同 Hemopurifier 給藥方案對上述指標的影響。提醒各位，這是一項 9 至 18 名受試者的研究，旨在評估 Hemopurifier 治療的安全性與可行性，並在實體腫瘤受試者中（其疾病在包含抗 PD-1 藥物 KEYTRUDA 或 Opdivo 的治療下維持穩定或仍在進展）確定適當的給藥間隔。接下來談我們的臨床前活動。

We are advancing our preclinical extracellular vesicle research activities, including studies evaluating removal of EVs and plasma samples from patients with rheumatoid arthritis and chronic kidney disease. Platelet-derived extracellular vesicles and their cargo have been noted to play a pathogenic role in rheumatoid arthritis. EVs in patients with chronic kidney disease have been demonstrated to contribute to congestive heart failure in this population. These efforts support the concept of a pipeline within a single device with EV removal as the primary mechanism of action. Separately, we continued our evaluation of the Hemopurifier's compatibility with a simplified blood pump system developed by Stavro Medical.

我們正推進臨床前細胞外囊泡（EV）研究活動，包括評估從類風濕性關節炎與慢性腎臟病患者的血漿樣本中移除 EV 的研究。已有研究指出，血小板來源的細胞外囊泡及其所攜帶的內容物在類風濕性關節炎中扮演致病角色。亦已證實，慢性腎臟病患者的 EV 會促成該族群的鬱血性心衰竭。這些工作支持「在單一裝置內建立一條產品管線」的概念，其中移除 EV 為主要作用機制。此外，我們也持續評估 Hemopurifier 與 Stavro Medical 開發之簡化血液幫浦系統的相容性。

Initial testing assessed flow rates and transfer of dye fluid to the Hemopurifier. These assessments have been completed and were successful. Future studies being considered right now, including the use of blood or plasma and removal of surrogate markers for extracellular vesicles by the Hemopurifier using this blood pump system. We believe that freeing the Hemopurifier up from a dialysis machine, dialysis unit and a large double lumen dialysis catheter would improve the number of physicians able to perform the Hemopurifier treatment and increase the number of places where such a treatment could be performed. For the patient, this could translate into having a less invasive vascular catheter placed and being able to receive their treatment in their therapeutic home.

初步測試評估了流速以及染料液體向 Hemopurifier 的傳輸。這些評估已完成且結果成功。目前正在考量的後續研究包括：使用血液或血漿，並在此血液幫浦系統下由 Hemopurifier 移除細胞外囊泡的替代標記（surrogate markers）。我們相信，若能讓 Hemopurifier 不再依賴透析機、透析單位以及大型雙腔透析導管，將可增加能執行 Hemopurifier 治療的醫師人數，並擴大可進行此治療的場所。對病患而言，這可能意味著可置放侵入性較低的血管導管，並能在其治療的「居家場域」接受治療。

Aethlon Medical is closely monitoring the evolving outbreak of the Bundibugyo species of Ebola in the Democratic Republic of the Congo and Uganda. The company has previously published in vitro removal data on the Marburg and Zaire species of Ebola from both cell culture fluid and plasma by a miniature version of the Hemopurifier. During the 2014 Zaire outbreak, a single 6.5-hour Hemopurifier treatment of a critically ill Ebola patient with multi-organ failure was associated with a 2-log reduction in viral load and clinical recovery. In December 2014, the FDA approved a compassionate use protocol as a supplement to our open IDE for life-threatening viral infections for which there is no treatment. This compassionate use protocol allows for the treatment of up to 20 subjects at up to 10 institutions in the U.S.

Aethlon Medical 正密切監測剛果民主共和國與烏干達 Bundibugyo 型伊波拉病毒疫情的持續演變。公司先前已發表體外移除數據，顯示 Hemopurifier 的微型版本可從細胞培養液與血漿中移除馬堡（Marburg）與薩伊（Zaire）型伊波拉病毒。在 2014 年薩伊型疫情期間，對一名多重器官衰竭、病情危急的伊波拉病患進行單次 6.5 小時的 Hemopurifier 治療，與病毒量下降 2 個對數（2-log）及臨床康復相關。2014 年 12 月，FDA 核准了一項同情使用（compassionate use）方案，作為我們針對無治療選項之危及生命病毒感染的開放式 IDE 的補充。此同情使用方案允許在美國最多 10 家機構治療最多 20 名受試者。

Recent interactions with the FDA have confirmed that this protocol remains open for enrollment. Aethlon has shared the above information with both the World Health Organization's R&D Blueprint Expert Panel as well as the National Emerging Special Pathogens Training and Education Center, known as NETEC, who works closely with the 13 U.S. regional special pathogen treatment centers that would treat a patient with Ebola in the U.S. should it happen.

近期與 FDA 的互動已確認該方案仍開放招募受試者。Aethlon 已將上述資訊分享給世界衛生組織（WHO）的研發藍圖（R&D Blueprint）專家小組，以及國家新興特殊病原體訓練與教育中心（NETEC）。NETEC 與美國 13 個區域特殊病原體治療中心密切合作；若美國境內發生伊波拉病例，這些中心將負責治療患者。

With that, I'll turn the call back over to Jim for the financial discussion and questions.

接下來我把電話交回給 Jim，進行財務說明並回答問題。

Thanks, Steve, and good afternoon again, everyone. Turning briefly to the financials. As of March 31, 2026, we had approximately $5 million in cash and cash equivalents which provide resources to support ongoing clinical and research activities. Subsequent to fiscal year-end, we further strengthened our balance sheet by raising approximately $1.85 million in net proceeds through our at-the-market program.

謝謝你，Steve，也再次向各位問好，下午好。簡要談一下財務狀況。截至 2026 年 3 月 31 日，我們持有約 500 萬美元的現金及約當現金，可提供資源以支持持續進行的臨床與研究活動。在會計年度結束後，我們也透過「隨市發行」（ATM）計畫募集約 185 萬美元的淨收益，進一步強化資產負債表。

Turning to some high-level expense analysis. Our consolidated operating expenses declined 21.9% year-over-year to approximately $7.3 million, reflecting continued expense discipline and operational efficiency while advancing our clinical and research priorities. That compares to a $9.3 million of operating expenses in the fiscal year ended March 31, 2025. The decrease was primarily due to a $1.1 million reduction in payroll and related expenses, a $500,000 reduction in general and administrative expenses and a $400,000 reduction in professional fees.

接著做一些高層次的費用分析。我們的合併營運費用年減 21.9% 至約 730 萬美元，反映在推進臨床與研究優先事項的同時，持續維持費用紀律與營運效率。相較之下，截至 2025 年 3 月 31 日止會計年度的營運費用為 930 萬美元。下降主要來自薪資及相關費用減少 110 萬美元、一般及行政費用減少 50 萬美元，以及專業服務費減少 40 萬美元。

Consistent with the reduction in operating expenses, the operating loss for the fiscal year decreased to approximately $7.3 million for fiscal 2026 from $9.3 million in the prior fiscal year. You can find more detail on these expense changes in our 10-K, which breaks down specific drivers by category.

與營運費用下降一致，本會計年度的營運虧損由前一年度的 930 萬美元降至 2026 會計年度約 730 萬美元。關於這些費用變動的更多細節，可在我們的 10-K 中查閱；其中按類別拆解了各項變動的具體驅動因素。

Our other income was approximately $142,000 for the fiscal year ended March 31, 2026, primarily reflecting interest income earned on cash balances. That compares to other expense of approximately $4 million in the prior fiscal year. The prior year amount included approximately $4.7 million of noncash financing-related charges. So overall, our net loss attributable to our common stockholders was $7.2 million for the fiscal year ended March 31, 2026, compared to a net loss of $13.4 million for the fiscal year ended March 31, 2025.

截至 2026 年 3 月 31 日止會計年度，我們的其他收益約為 14.2 萬美元，主要反映現金餘額所產生的利息收入。相較之下，前一會計年度的其他費用約為 400 萬美元。前一年度金額包含約 470 萬美元的非現金融資相關費用。因此，歸屬於普通股股東的淨損為截至 2026 年 3 月 31 日止會計年度的 720 萬美元，而截至 2025 年 3 月 31 日止會計年度的淨損為 1,340 萬美元。

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, 2026 and 2025, and the consolidated statements of operations for the fiscal years ended March 31, 2026 and 2025. We will file our annual report on Form 10-K following this call.

我們已在今天下午發布的新聞稿中納入這些盈餘結果及相關說明。該新聞稿亦包含 2026 年與 2025 年 3 月 31 日的資產負債表，以及截至 2026 年與 2025 年 3 月 31 日止會計年度的合併營運報表。我們將在本次電話會議後提交 Form 10-K 年度報告。

Our next earnings call for the fiscal first quarter ending June 30, 2026, will coincide with the filing of our quarterly report on Form 10-Q in August 2026.

我們下一次財報電話會議（截至 2026 年 6 月 30 日止的會計年度第一季）將與我們於 2026 年 8 月提交 Form 10-Q 季度報告的時間同步。

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

現在我們很樂意回答各位可能有的任何問題。接線員，請開放提問。

(Operator Instructions) Marla Marin, Zacks.

（接線員指示）Zacks 的 Marla Marin。

So a lot going on. So just a couple of housekeeping questions. I want to get back to something that I think you said, Jim, the compassionate use protocol, which is still open. Can you refresh us in terms of your -- it would seem to me based on my recollection of -- I know you treated some seriously ill COVID patients, but it would seem to me that you're well below that threshold that you cited of the number of potential patients to be treated and the number of medical centers.

目前有很多進展。我先問幾個行政性問題。我想回到一點，我記得你說過的，Jim，就是同情用藥方案仍然開放。能否幫我們更新一下——依我記憶，我知道你們曾治療過一些病情非常嚴重的 COVID 患者，但就我看來，你們似乎遠低於你提到的可治療潛在患者數量以及醫療中心數量的門檻。

I believe the Ebola protocol is relevant only to Ebola. So it would be up to 20 patients -- Ebola patients at 10 centers.

我相信伊波拉方案只與伊波拉相關。所以最多是 20 名患者——伊波拉患者，分布在 10 個中心。

Got it. Okay, so --

了解。好，那麼--

No, that compassionate use protocol is specific to Ebola and it's 20 patients at up to 10 centers.

沒錯，那個同情用藥方案是針對伊波拉的，最多 20 名患者、最多 10 個中心。

Okay. Got it. So it had -- it's completely separate from the patients that you had treated in the past under emergency.

好的。了解。所以它——與你們過去在緊急情況下治療過的患者是完全分開的？

Yes.

是的。

Okay, got it.

好的，了解。

That is correct. That is correct.

沒錯。沒錯。

Okay. Good. Can you give us a little more color on how you're planning to approach the preclinical activities around rheumatoid arthritis? I'm guessing that this is something that will be done in a very cost-efficient manner because that's what you've been doing in terms of expanding or extending your research activities outside the current ongoing trial. But can you give us some color and also some sense of what the time line there is?

好的。很好。你能否多談一些你們打算如何推進類風濕性關節炎相關的臨床前活動？我猜這會以非常具成本效益的方式進行，因為你們一直以來在擴展或延伸現有進行中試驗以外的研究活動時，都是這樣做的。但你能否提供一些更具體的說明，以及大致的時間表？

You want to take that or should I?

你要回答這題，還是我來？

Sure. So Marla, rheumatoid arthritis is just one of the many diseases where platelet-derived EVs, a sizable percentage of the EV population in our blood is implicated in the disease. What we did is the first instance is test healthy plasma to look for platelet removal of EVs -- platelet-derived EVs. And we did that in a single large volume healthy plasma sample. We subsequently purchased in a cost-effective way, a couple of additional healthy plasma samples.

當然。Marla，類風濕性關節炎只是眾多疾病之一；在這些疾病中，血液中的 EV（細胞外囊泡）族群有相當大比例來自血小板，而血小板來源的 EV 與疾病相關。我們首先做的是測試健康者血漿，觀察是否能去除血小板來源的 EV——也就是血小板衍生 EV。我們在一份單一的大體積健康血漿樣本上完成了該測試。之後我們以具成本效益的方式，另外購買了幾份健康血漿樣本。

And now we are purchasing large volume rheumatoid arthritis samples. And those are all being run at our lab with the focus on the platelet-derived EVs and the microRNA. So that work is currently underway. And then with the chronic kidney -- just finish -- also I mentioned chronic kidney disease. There's been recent publications that these patients have EVs that cause congestive heart failure, which is a huge source of morbidity and mortality in this population.

現在我們正在購買大體積的類風濕性關節炎樣本。這些樣本都在我們的實驗室進行分析，重點放在血小板來源的 EV 以及 microRNA。因此這項工作目前正在進行中。另外，關於慢性腎臟病——我也提到過慢性腎臟病。近期有文獻指出，這些患者的 EV 會導致鬱血性心衰竭，而這是該族群罹病與死亡的重要來源。

So we have purchased small samples of chronic kidney disease plasma, and we're testing them for binding to the resin in our device. And again, that work is being done in-house as well.

因此我們已購買少量慢性腎臟病血漿樣本，並測試其與我們裝置中樹脂的結合情形。同樣地，這項工作也在內部進行。

And how should we think about next steps there? Because in the past, I know you've contributed to working on peer-reviewed papers. You've presented at different medical presentations. So how should we think about next steps depending upon the outcome of the testing that you're doing now?

那接下來的步驟應該如何看待？因為過去我知道你們曾參與撰寫同儕審查論文。你們也在不同的醫學會議上發表。所以，依據你們目前測試結果的不同，接下來的步驟應該怎麼規劃？

Yes, sure. So we published a preprint in one of the preprint servers on removal of platelet-derived EVs from a single healthy plasma specimen. The feedback we received is we needed to run more samples and that we needed to also go into a relevant disease sample.

好的，當然。我們曾在某個預印本平台上發布預印本，內容是從單一健康血漿檢體中去除血小板來源 EV。我們收到的回饋是需要跑更多樣本，並且也需要納入相關疾病樣本。

So with that in mind, we got the additional healthy plasma samples, and we got the rheumatoid arthritis samples. And we think that this will be the data needed to satisfy the reviewers and turn -- not turn, but have in addition to a preprint and actually peer-reviewed publication on the subject with respect to our device. Same thing with the CKD, chronic kidney disease samples, we'll look at binding to our resin, and we would then plan on turning that into an abstract at a medical meeting and a peer-reviewed publication. Again, filling -- trying to fill the preclinical pipeline.

基於此，我們取得了額外的健康血漿樣本，也取得了類風濕性關節炎樣本。我們認為這些資料將足以滿足審稿人的要求，並使我們不只是停留在預印本，而是能就我們裝置在該主題上的結果，進一步形成同儕審查的正式論文發表。慢性腎臟病（CKD）樣本也是同樣做法；我們會觀察其與我們樹脂的結合情形，接著規劃在醫學會議上提交摘要並發表同儕審查論文。同樣地，就是在充實——嘗試充實臨床前研發管線。

Right. Got it. And building your database in the most cost-effective way that you can. Is that the right way to think about it?

對。了解。並且以你所能做到的最具成本效益的方式來建立你的資料庫。這樣理解對嗎？

Yeah, I think that's a good way to say it.

是的，我覺得這樣說很貼切。

Okay. And then last question from me. So you've treated the first participant in Cohort 3. And I think at your last conference call, you said you had -- you were very pleased with the interest that you had seen in participating in the trial. Is that still something that's operating in terms of moving on to treating the next participant?

好的。那我最後一個問題。所以你們已經治療了第 3 隊列（Cohort 3）的第一位受試者。我記得在上次電話會議上，你提到你們對於看到的試驗參與意願非常滿意。這是否仍然有助於推進到治療下一位受試者？

Yeah. No, we've seen good engagement and commitment from our 3 sites in terms of screening activity. So that remains a positive, bodes well. We did have a few patients that became screen failures for not meeting an inclusion or exclusion criteria. That happens in every study, unavoidable. So -- but the most important thing for me is that the engagement is there and the activity is there.

是的。我們在 3 個試驗中心的篩選活動方面，確實看到良好的參與度與投入。所以這仍然是正面的訊號，前景看好。我們確實有幾位病患因未符合納入或排除標準而成為篩選失敗。每個研究都會發生，無可避免。所以——但對我來說最重要的是，參與度在、活動量也在。

Okay, thank you.

好的，謝謝。

Thank you, Marla.

謝謝你，Marla。

Anthony Vendetti, Maxim Group.

Maxim Group 的 Anthony Vendetti。

Yes, thanks. So just in terms of the efficacy, any endpoints you're looking for or readouts on an efficacy standpoint because I know obviously, the first studies are safety. But what are you looking for in terms of efficacy? And are you able to report on those other than internally know about it, are you able to publish that data?

是的，謝謝。就療效而言，你們有在看哪些終點或療效面的讀出嗎？因為我知道很明顯，第一階段研究以安全性為主。但你們在療效方面想看到什麼？另外，除了內部掌握之外，你們是否能對外報告或發表那些數據？

Yes. So remember, the primary endpoint for this study is safety. Secondary endpoint is surrogate markers looking at the Hemopurifier activity, and those would be EV removal, extracellular vesicle removal and effects on T cells, including antitumor T cells. We previously reported on some qualitative observations from the first cohort, and those are in a prior press release where we saw some changes in EVs and T cells in the right direction. As I just said, we've just received measurements from Cohort 2.

可以。請記得，本研究的主要終點是安全性。次要終點是替代性指標，用來觀察 Hemopurifier 的活性，包括 EV 清除（extracellular vesicle，細胞外囊泡清除）以及對 T 細胞的影響，包含抗腫瘤 T 細胞。我們先前已就第一隊列的一些質性觀察做過報告，並在先前的新聞稿中提到，我們看到 EV 與 T 細胞朝正向方向變化。如我剛才所說，我們剛收到第 2 隊列的測量結果。

But the big thing that will occur is at the end of the study, there'll be a formal statistical analysis looking at those dosing regimens between the 3 different dosing regimens. And that will look magnitude of EV decreases and duration of EV decreases as comparing the 3 strategies and again, magnitude and duration of positive effects on T cells. Those will be the major readouts. The study is not randomized and is small such that clinical outcomes are not a primary outcome or secondary outcome of the study. It's just way too small for such a -- for clinical efficacy.

但真正重要的是，在研究結束時會有正式的統計分析，來比較 3 種不同給藥方案之間的差異。分析將比較 3 種策略下 EV 降低的幅度與持續時間，並同樣評估對 T 細胞正向影響的幅度與持續時間。這些會是主要讀出。本研究未隨機分派且樣本數小，因此臨床結局不是主要或次要終點。就臨床療效而言，規模實在太小。

Right, right. No, of course, at this stage. Yes. Certainly for statistical significance in terms of clinical efficacy. But nonetheless, if they're doing well and you're able to show that, even though that's not the primary endpoint, that's always encouraging.

對，對。當然，在這個階段。是的。要在臨床療效上達到統計顯著性當然不容易。但即便如此，如果病患狀況良好、你們也能呈現出來，即使不是主要終點，也總是令人鼓舞。

What about any signals suggesting that the Hemopurifier may enhance the therapies like KEYTRUDA or Opdivo.

那有沒有任何訊號顯示 Hemopurifier 可能增強像 KEYTRUDA 或 Opdivo 這類療法的效果？

Yes. I would just call your attention to that prior press release that shows that the EVs, including tumor-derived EVs went down in the first cohort and that there were improvements in T cells and antitumor T cells in the first cohort.

有。我會請你參考先前那份新聞稿：其中顯示第一隊列的 EV（包括腫瘤來源 EV）下降，且第一隊列的 T 細胞與抗腫瘤 T 細胞有所改善。

Okay. And then any biomarkers or exosome-related findings that have emerged as well? I guess the EVs is what you're talking about?

好的。那也有任何生物標記或與外泌體相關的發現出現嗎？我想你說的就是 EV？

Yes. In the first cohort of particular interest to us was that EVs carrying PD-L1 on the surface went down during the treatment. These particular population of EVs have been implicated as a cause of resistance to anti-PD-1 therapy. So the fact that they went down with treatment, again, at least in the first cohort was a positive signal that will have to be corroborated, confirmed in the subsequent cohorts and the magnitude and duration will have to be examined. But that was of particular interest to me at least.

是的。在第一隊列中，我們特別感興趣的是：表面帶有 PD-L1 的 EV 在治療期間下降。這一特定族群的 EV 被認為可能是對抗 PD-1 治療產生抗藥性的原因之一。因此，它們在治療後下降——至少在第一隊列——是一個正向訊號；但仍需在後續隊列中加以佐證與確認，並檢視其幅度與持續時間。但至少對我而言，這點特別值得關注。

Okay. So, so far, to sum it up, if I could do so, everything is moving in the direction you would want it to be moving in terms of what you're seeing so far with the patients that have been treated.

好的。所以如果我可以總結一下：到目前為止，就你們在已治療病患身上看到的結果而言，一切都朝你們希望的方向發展。

Correct.

正確。

Okay, good. Thank you very much. I'll hop back in the queue. Appreciate it.

好的，很好。非常感謝。我回到排隊等候。感謝。

Thank you, Anthony.

謝謝你，Anthony。

Jeremy Pearlman, Maxim Group.

Maxim Group 的 Jeremy Pearlman。

Hello.

你好。

Hi, Jeremy.

嗨，Jeremy。

Yeah, I think that was -- I didn't dial in. I think the operator by action did that. I'm sorry. Anthony already asked the question. Thank you.

是的，我想那是——我沒有撥入。我想是接線員操作把我接進來的。不好意思。Anthony 已經問過那個問題了。謝謝。

Got it. Okay.

了解。好的。

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

問答環節到此結束。我想把會議交回給 Jim Frakes，請他做結語。請開始。

Thank you. In closing, we remain focused on advancing the Hemopurifier platform through disciplined clinical execution and careful capital management. We appreciate your continued interest and support and look forward to speaking with you in August. Thank you very much. Goodbye.

謝謝。最後，我們仍專注於透過嚴謹的臨床執行與審慎的資本管理，推進 Hemopurifier 平台。感謝各位持續的關注與支持，我們期待在 8 月與各位再度交流。非常感謝。再見。

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

本次電話會議到此結束。感謝各位參加今天的簡報。您現在可以掛線。