Aethlon Medical Inc (AEMD) 2026 Q1 法說會逐字稿

Good afternoon, and welcome to the Aethlon Medical first quarter fiscal 2026 earnings and corporate update. Please note this event is being recorded. I would now like to turn the conference over to Jim Frakes, Chief Executive Officer and Chief Financial Officer. Please go ahead, sir.

下午好，歡迎收看 Aethlon Medical 2026 財年第一季財報及公司更新。請注意，此事件正在被記錄。現在，我想將會議交給執行長兼財務長 Jim Frakes。先生，請繼續。

Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's fiscal first quarter 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 PM Eastern Time today, Aethlon Medical released financial results for its fiscal first quarter ended June 30, 2025.

謝謝接線員，大家下午好。歡迎參加 Aethlon Medical 2026 財政年度第一季財報電話會議。我叫 Jim Frakes，是 Aethlon Medical 的執行長兼財務長。今天美國東部時間下午 4:15，Aethlon Medical 發布了截至 2025 年 6 月 30 日的第一財季財務業績。

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.

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。在介紹並閱讀公司前瞻性聲明免責聲明之後，我們的首席醫療官 Steven LaRosa 博士和我將概述 Aethlon 的策略和最新發展。

I will then make some brief remarks on Aethlon's financials. We will then open up the call for the Q&A session. 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.

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。在我們開始電話會議的業務部分之前，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召開之日的預期和假設。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有重大差異的因素可在本公司截至 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 update portion of this call. First, I'd like to note that because of our March 31 fiscal year, we report our fourth quarter and then the ensuing first quarter quite close in time, basically six weeks apart.

現在，我們將討論本次通話的業務更新部分。首先，我想指出的是，由於我們的財政年度是 3 月 31 日，我們報告第四季度和隨後的第一季的時間相當接近，基本上相隔六週。

As a result, in this earnings call, we will also touch on some of the late-breaking news from our previous earnings call in late June. Overall, we are pleased with the progress in our Australian oncology trial. Dr. LaRosa will cover the specifics on that trial shortly, but I wanted to give some high-level thoughts first.

因此，在本次財報電話會議上，我們也將談到 6 月底上次財報電話會議上的一些最新消息。總體而言，我們對澳洲腫瘤學試驗的進展感到滿意。LaRosa 博士很快就會介紹該試驗的具體情況，但我想先給出一些高層次的想法。

Keep in mind that several of these points are forward-looking statements, as I just noted. In the first quarter, we advanced our lead oncology indication clinical program, delivered preclinical results supporting broader applications including long COVID, all while significantly reducing operating expenses.

請記住，正如我剛才指出的，其中幾點都是前瞻性的陳述。在第一季度，我們推進了領先的腫瘤適應症臨床計劃，提供了支持包括長期 COVID 在內的更廣泛應用的臨床前結果，同時大幅降低了營運成本。

Our focus remains on moving the Hemopurifier towards regulatory approval and expanding use across multiple diseases. While we received formal approval from India's Central Drug Standard Control Organization, or CDSCO to initiate a similar oncology trial at Medanta Medicity Hospital in New Delhi, India.

我們的重點仍然是推動血液淨化器獲得監管部門的批准並擴大其在多種疾病中的應用。同時，我們獲得了印度中央藥品標準控制組織（CDSCO）的正式批准，在印度新德里的 Medanta Medicity 醫院進行類似的腫瘤學試驗。

Discussions with our India-based CRO showed first patient treatment would likely slip to early 2026. Given this extended time line and our broader strategic priorities, we decided not to proceed with the India study. This choice is about focus, not just savings, though we expect to conserve $500,000 to $1 million by this decision.

與我們位於印度的 CRO 的討論表明，第一位患者的治療可能會推遲到 2026 年初。考慮到這一延長的時間線和我們更廣泛的戰略重點，我們決定不再繼續進行印度研究。這個選擇是為了重點，而不僅僅是為了節省，儘管我們預計這項決定可以節省 50 萬至 100 萬美元。

Based on our current progress in Australia, we could complete treatments by late 2025 or early 2026, analyze data and be in a position to apply for a PMA or efficacy trial in Australia and engage strategic partners.

根據我們目前在澳洲的進展，我們可以在 2025 年底或 2026 年初完成治療，分析數據，並能夠在澳洲申請 PMA 或療效試驗並與策略合作夥伴合作。

If we were still early in the Indian trial at that point, regulators or potential strategic partners could require us to finish it first, delaying our path forward. Avoiding that risk is why we are focusing our resources in Australia, which keeps us on the fastest toward our next milestone.

如果我們當時仍處於印度試驗的早期階段，監管機構或潛在的戰略合作夥伴可能會要求我們先完成試驗，從而延緩我們的前進步伐。為了避免這種風險，我們將資源集中在澳大利亞，這使我們能夠以最快的速度邁向下一個里程碑。

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, particularly in long COVID and our recent preclinical data regarding the removal of platelet-derived extracellular vesicles or EVs. Steve?

現在我將電話轉給 LaRosa 博士，他將介紹澳洲腫瘤學試驗的最新情況以及我們的研發工作，特別是在長期 COVID 方面的進展以及我們最近關於去除血小板衍生的細胞外囊泡或 EV 的臨床前數據。史蒂夫？

Thank you, Jim. Hello, everyone. I'm joining you live from the Keystone Symposium Conference on Long COVID in Santa Fe, New Mexico, where last evening, I presented preclinical data in long COVID, more about that in a little bit. First, I'd like to give you our progress in our lead indication in oncology, our Australian clinical trial of patients with solid tumors not responding to immunotherapy with anti-PD-1 agents.

謝謝你，吉姆。大家好。我將在新墨西哥州聖達菲舉行的長期 COVID Keystone 研討會上現場直播，昨晚，我在會上介紹了長期 COVID 的臨床前數據，稍後我會詳細介紹。首先，我想向您介紹我們在腫瘤學領域的主要適應症方面取得的進展，即我們在澳洲針對對抗 PD-1 藥物免疫療法無反應的實體瘤患者進行的臨床試驗。

We have completed Hemopurifier treatments in the three patients in our first cohort. The first patient completed a Hemopurifier treatment at our site at Royal Adelaide Hospital in January, and patients two and three were treated at Royal North Shore Hospital in Sydney on June 2 and June 16 of this year.

我們已經對第一批三名患者完成了血液淨化器治療。第一位患者於今年 1 月在我們位於皇家阿德萊德醫院的診所完成了血液淨化器治療，第二位和第三位患者於今年 6 月 2 日和 6 月 16 日在悉尼皇家北岸醫院接受了治療。

All three participants completed the entire four-hour Hemopurifier treatment without any device deficiencies and no immediate complications. At the prespecified seven-day safety follow-up period, none of these three participants experienced a dose-limiting toxicity or a device-related serious adverse event. The second patient enrolled, unfortunately, went on to die from progression of his cancer and can only provide a one-week follow-up worth of data.

三名參與者都完成了整個四小時的血液淨化器治療，沒有任何設備缺陷，也沒有立即出現併發症。在預先指定的七天安全追蹤期內，這三名參與者均未出現劑量限制性毒性或與設備相關的嚴重不良事件。不幸的是，第二名患者因癌症惡化而死亡，並且只能提供一週的追蹤數據。

An independent Data Safety Monitoring Board known as the DSMB convened on July 11, 2025, to review the safety data on these first three patients in the first cohort. Following a closed session deliberation, the DSMB provided Aethlon Medical's senior leadership with a recommendation to advance to our second treatment cohort where patients will receive two Hemopurifier treatments during a one-week period.

一個被稱為 DSMB 的獨立資料安全監測委員會於 2025 年 7 月 11 日召開會議，審查第一批前三名患者的安全資料。經過閉門會議審議後，DSMB 向 Aethlon Medical 的高層領導提出了建議，即進入我們的第二組治療，患者將在一周內接受兩次血液淨化器治療。

All three of our sites in Australia are actively screening patients for this second cohort. These sites are screening under an amended protocol that allows patients on either monotherapy or combination therapy that includes pembrolizumab or nivolumab. This protocol amendment was performed to reflect changes in standard of care, leaning now more towards combo therapy and it thus increases the potential pool of patients for the study.

我們在澳洲的所有三個站點都在積極篩選第二批患者。這些站點正在根據修訂後的方案進行篩選，該方案允許患者接受單一療法或包括 pembrolizumab 或 nivolumab 在內的聯合療法。該協議修訂是為了反映護理標準的變化，現在更傾向於聯合治療，從而增加了研究的潛在患者數量。

The laboratory of Professor Georges Grau at the University of Sydney continues to work on the central lab test on the first patient cohort samples to look for the effects of the Hemopurifier on extracellular vesicle numbers and antitumor T cell function. We would expect to be able to make some observations of this data sometime in September 2025. As a reminder, the primary endpoint of this approximate 9 to 18-patient safety, feasibility and dose-finding study is safety.

雪梨大學喬治斯·格勞教授的實驗室繼續對第一批患者樣本進行中央實驗室測試，以尋找血液淨化器對細胞外囊泡數量和抗腫瘤 T 細胞功能的影響。我們預計能夠在 2025 年 9 月的某個時候對這些數據進行一些觀察。提醒一下，這項約 9 到 18 名患者的安全性、可行性和劑量探索研究的主要終點是安全性。

The trial will monitor for any adverse events and clinically significant changes in lab tests of Hemopurifier-treated patients with solid tumors who have stable or progressive disease while on a regimen that includes either KEYTRUDA or OPDIVO anti-PD-1 therapy.

該試驗將監測接受 Hemopurifier 治療且病情穩定或進展的實體瘤患者在接受包括 KEYTRUDA 或 OPDIVO 抗 PD-1 療法的方案期間出現的任何不良事件和實驗室測試中的臨床顯著變化。

The patients, as mentioned, it's designed in three cohorts. The first we've completed, the second cohort where patients get two treatments in a one-week period and the third cohort where the patients get three Hemopurifier treatments in a one-week period.

如上所述，患者被分為三組。我們已經完成了第一批治療，第二批患者在一週內接受兩次治療，第三批患者在一週內接受三次血液淨化器治療。

As mentioned, in addition to monitoring safety, we're examining the number of Hemopurifier treatments needed to decrease the concentration of extracellular vesicles, and if these decreases in EV numbers improve the body's own natural ability to attack tumor cells.

如上所述，除了監測安全性之外，我們還在研究降低細胞外囊泡濃度所需的血液淨化器治療次數，以及 EV 數量的減少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 dosing of a later efficacy and safety trial, including a PMA or premarket approval study that is required by the FDA and other regulatory agencies. Currently, only approximately 30% to 40% of patients who receive pembrolizumab or nivolumab will have a lasting clinical response to these agents.

這些探索性的中心實驗室分析有望為後期的療效和安全性試驗提供劑量信息，包括 FDA 和其他監管機構要求的 PMA 或上市前批准研究。目前，接受 pembrolizumab 或 nivolumab 治療的患者中只有約 30% 至 40% 會對這些藥物產生持久的臨床反應。

Extracellular vesicles produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve the therapeutic response rates to the anti-PD-1 drugs. In preclinical studies, the Hemopurifier has been able to decrease the number of EVs in cancer patient samples.

腫瘤產生的細胞外囊泡與癌症的擴散以及抗 PD-1 療法的抗藥性有關。Aethlon 血液淨化器旨在結合並從血液中去除這些 EV，這可能會提高抗 PD-1 藥物的治療反應率。在臨床前研究中，血液淨化器已經能夠減少癌症患者樣本中的 EV 數量。

Now I'd like to segue to our R&D preclinical activities. Last evening, August 12, 2025, Aethlon presented a poster at the Keystone Symposium on long COVID and other post-acute infectious syndromes being held in Santa Fe, New Mexico. Long-standing symptoms following acute COVID-19 infection known as long covid has been determined to affect approximately 400 million individuals worldwide with a global economic burden of approximately $1 trillion per year.

現在我想談談我們的研發臨床前活動。2025 年 8 月 12 日昨晚，Aethlon 在新墨西哥州聖達菲舉行的關於長期 COVID 和其他急性後感染綜合徵的 Keystone 研討會上展示了一張海報。急性 COVID-19 感染後的長期症狀（稱為長期新冠病毒）已確定影響全球約 4 億人，每年造成全球約 1 兆美元的經濟負擔。

This data can be found in a Nature Medicine 2024 publication. The presentations at this conference reviewed the clinical trials that have been conducted to date and show that there is currently no agent that is approved for the treatment of long COVID, indicating a large unmet medical need. Extracellular vesicles have been implicated in the pathogenesis of long COVID.

這些數據可以在《自然醫學 2024》出版物中找到。本次會議的報告回顧了迄今為止進行的臨床試驗，表明目前尚無任何藥物已被批准用於治療長期 COVID，這表明存在大量未滿足的醫療需求。細胞外囊泡與長期 COVID 的發病機制有關。

Since we had previously demonstrated removal of extracellular vesicles by the Hemopurifier in emergency use patients with severe acute COVID-19 infection, we hypothesized that the patients with long COVID would have extracellular vesicles with the mannose sugar on their surface that would be amenable to removal by our device.

由於我們之前已經證明血液淨化器可以在急診重症急性 COVID-19 感染患者中去除細胞外囊泡，因此我們假設長期 COVID 患者的細胞外囊泡表面會有甘露糖，而這些囊泡可以透過我們的設備去除。

With this in mind, we partnered with investigators at the University of California San Francisco Medical Center, Long COVID link cohort, and they provided us samples from -- blood samples from patients with long COVID as well as people who had COVID but had fully recovered.

考慮到這一點，我們與加州大學舊金山醫學中心長期 COVID 連結隊列的研究人員合作，他們向我們提供了來自長期 COVID 患者以及已完全康復的 COVID 患者的血液樣本。

The data we presented last evening demonstrated that both large and small extracellular vesicles from long COVID patients found to the GNA lectin and lectin affinity resin, respectively, in our device. We had active discussions with a number of participants, and we will take this feedback back to Aethlon to discuss potential next steps and other collaborations.

我們昨晚展示的數據表明，來自長期 COVID 患者的大細胞外囊泡和小細胞外囊泡分別在我們的設備中找到了 GNA 凝集素和凝集素親和樹脂。我們與許多參與者進行了積極的討論，並將把這些回饋回饋給 Aethlon，討論潛在的後續步驟和其他合作。

Since this data has now been presented publicly, we will share this poster on our Aethlon medical site in the very near future. On May 12, 2025, the results of our preclinical ex vivo study entitled ex vivo removal of CD41-positive platelet microparticles from plasma by a medical device containing Galanthus nivalis agglutinin resin was published in the preprint vehicle bioRxiv and is publicly available.

由於這些數據現已公開，我們將在不久的將來在我們的 Aethlon 醫療網站上分享這張海報。2025 年 5 月 12 日，我們的臨床前離體研究結果（題為「透過含有雪花蓮凝集素樹脂的醫療器材從血漿中離體移除 CD41 陽性血小板微粒」）發表在預印本載體 bioRxiv 上，並可供公眾使用。

This manuscript has also been submitted to a peer-reviewed publication for review. Platelet-derived extracellular vesicles are the most numerous EV population in the body and are released by platelets in response to a variety of stimuli. The cargo contained within these platelet-derived EVs have been noted to take part in damage to blood vessels, activation of immune cells and spread of tumor cells.

該手稿也已提交給同行評審出版物進行審查。血小板衍生的細胞外囊泡是體內數量最多的囊泡群體，由血小板在回應各種刺激時釋放。據悉，這些血小板衍生的電動車所含的貨物會造成血管損傷、免疫細胞活化和腫瘤細胞擴散。

Excessive levels of PD-EVs have been implicated in a myriad of diseases, not only cancer, but also lupus, systemic sclerosis, multiple sclerosis, Alzheimer's disease, sepsis and acute and long COVID. As a matter of fact, this morning, a presentation from the Paxlovid study indicated that platelets, activated platelets are a source of viral persistence within long COVID.

過量的 PD-EV 與多種疾病有關，不僅包括癌症，還包括狼瘡、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。事實上，今天上午，Paxlovid 研究的一份報告表明，血小板、活化血小板是長期 COVID 病毒持續存在的來源。

We hypothesized in our publication analysis and our study that the Aethlon hemopurifier, which contains the proprietary GNA affinity resin might be able to bind these platelet-derived EVs from plasma. In this experiment, we took 200 milliliters of healthy donated human plasma and circulated it over our Aethlon Hemopurifier to simulate a clinical Hemopurifier session. The data revealed that we removed 98.5% of platelet-derived EVs at a time point equivalent to a four-hour treatment in a patient.

我們在出版物分析和研究中假設，含有專有 GNA 親和樹脂的 Aethlon 血液淨化器可能能夠結合來自血漿的這些血小板衍生的 EV。在這個實驗中，我們取了 200 毫升健康捐贈的人體血漿，並透過我們的 Aethlon 血液淨化器進行循環，以模擬臨床血液淨化器療程。數據顯示，我們在相當於患者接受四小時治療的時間點清除了 98.5% 的血小板衍生 EV。

The results of this study support our current Australian clinical trial in oncology as well as open the investigation of the hemopurifier in the diseases I just mentioned.

這項研究的結果支持了我們目前在澳洲進行的腫瘤學臨床試驗，並開啟了血液淨化器在我剛才提到的疾病中的研究。

With that, I'll turn the call back over to Jim for the financial discussion, and then we will take questions. Jim?

說完這些，我將把電話轉回給吉姆，討論財務問題，然後我們將回答問題。吉姆？

Thanks, Steve, and good afternoon again, everyone. Let's touch briefly on the financials now. As of June 30, 2025, we had a cash balance of approximately $3.8 million. For the three months ended June 30, 2025, our consolidated operating expenses were approximately $1.8 million. That's down roughly $800,000 or 32% from $2.6 million a year ago.

謝謝，史蒂夫，大家下午好。現在讓我們簡單談談財務狀況。截至 2025 年 6 月 30 日，我們的現金餘額約為 380 萬美元。截至 2025 年 6 月 30 日的三個月，我們的合併營運費用約為 180 萬美元。與一年前的 260 萬美元相比，下降了約 80 萬美元，降幅為 32%。

Most of the improvement came from payroll-related savings, including the absence of executive severance recorded last year, lower headcount and a related drop in stock-based compensation. We also saw a meaningful reduction in legal fees after transitioning to a new firm and lower scientific consulting costs with the wrap-up of a project.

大部分改善來自與薪資相關的節省，包括去年沒有記錄高階主管遣散費、員工人數減少以及相關的股票薪酬下降。我們也發現，在轉入新公司後，法律費用大幅減少，隨著計畫的結束，科學諮詢成本也降低了。

Our general and administrative expenses were modestly lower as well, helped by reduced insurance costs, but we did see an uptick in clinical trial spending as our trial advances. All in, these efficiencies brought our operating loss down to $1.8 million compared to $2.6 million in last year's June quarter, reflecting solid progress in aligning our resources with our strategic priorities.

由於保險費用降低，我們的一般和行政費用也略有下降，但隨著試驗的進展，我們確實看到臨床試驗支出增加。總而言之，這些效率使我們的營運虧損從去年 6 月季度的 260 萬美元降至 180 萬美元，反映出我們在資源與策略重點的協調方面取得了堅實的進展。

You can find more detail on these expense changes in our 10-Q, which breaks down specific drivers by category. We included these earnings results and related commentary in our press release issued this afternoon. The release also included the balance sheet for June 30, 2025, and the statements of operations for the three-month periods ended June 30, 2025, and 2024. We will file our quarterly report on Form 10-Q following this call.

您可以在我們的 10-Q 中找到有關這些費用變化的更多詳細信息，其中按類別細分了具體的驅動因素。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 6 月 30 日的資產負債表以及截至 2025 年 6 月 30 日和 2024 年 6 月 30 日的三個月期間的經營報表。本次電話會議結束後，我們將提交 10-Q 表季度報告。

Our next earnings call for the fiscal second quarter ending September 30, 2025, will coincide with the filing of our quarterly report on Form 10-Q in November 2025.

我們下一次關於截至 2025 年 9 月 30 日的第二財季財報電話會議將與我們 2025 年 11 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。

Thank you. So there's a lot going on. And -- just remind us, I think you said in the press release that the primary endpoint of the study in Australia is safety. And so far, with the first cohort having been treated, it looks like there's no adverse events related to treatment with the Hemopurifier. So it looks like you're on track to meet the primary endpoint. Is that the right way to think about it?

謝謝。所以有很多事情發生。而且—提醒我們一下，我認為您在新聞稿中說過，澳洲這項研究的主要終點是安全性。到目前為止，第一批患者已經接受治療，看起來沒有出現與血液淨化器治療相關的不良事件。因此看起來您正按計劃達到主要終點。這是正確的思考方式嗎？

Steve, do you want to take that one?

史蒂夫，你想拿那個嗎？

Yeah. So we've passed the first -- it's a three-cohort study. We've passed the first cohort, an independent Data Safety Monitoring Board made up of experts in oncology and nephrology, reviewed the safety data and said, move forward to the second cohort where patients get to treatment. So we think it's a big hurdle to have passed.

是的。我們已經通過了第一項——這是一項三組隊列研究。我們已經通過了第一批，由腫瘤學和腎臟病學專家組成的獨立數據安全監測委員會審查了安全數據，並表示將進入第二批，讓患者接受治療。所以我們認為這是一個需要克服的重大障礙。

Okay. So now trying to put in perspective on preclinical data, an extremely high metric, 98.5% of extracellular vesicles were removed in simulated treatment. But now we're looking at actual treatment in a clinical study. Those -- the kind of data that we should expect to see, I mean, I don't know, it would seem to me that number in a laboratory setting is not really what we should expect to see out of this study with actual participants, patients who are ill. Is that not the way you're thinking about it?

好的。因此，現在嘗試從臨床前數據的角度來看待這個問題，這是一個極高的指標，在模擬治療中，98.5% 的細胞外囊泡被去除。但現在我們正在臨床研究中尋找實際的治療方法。這些 — — 我們應該期望看到的數據，我的意思是，我不知道，在我看來，實驗室環境中的數字並不是我們真正期望從實際參與者、患病患者的研究中看到的數字。您不也是這麼想的嗎？

Yeah. No, I think you're tracking perfectly, Marla. What's in the lab is not -- what the proof is in the pudding is in what happens in actual patients. So hopefully, soon, we'll have our data from the first cohort from the Grau lab? And what matters ultimately is the reduction in actual -- from patients who have been treated.

是的。不，我認為你的追蹤非常準確，瑪拉。實驗室裡的東西並不是真的——真正的證據是在實際病人身上發生的事情。那麼，希望我們很快就能獲得來自 Grau 實驗室第一批數據？最終重要的是接受治療的患者的實際減少量。

Okay. Great. And switching now, Jim, I have a question for you on -- you've really, really done, I think, as much as you can do to try to cut expenses here. It doesn't seem that there's any more that you can do.

好的。偉大的。現在換個話題，吉姆，我有一個問題想問你——我認為，你已經盡了最大的努力來削減開支。看起來您已經沒有什麼可以做的了。

The decision to not move forward with the trial in India, strategic as well as possibly some element of cost containment, but more so strategic. Have you thought in terms of what that implies for you right now in terms of -- obviously, you will need cash again at some point to continue funding clinical research. But have you thought about what that means for you in terms of timing?

決定不在印度進行試驗，這既有戰略意義，也可能是出於成本控制的考慮，但更多的是戰略意義。您是否想過這對您現在意味著什麼——顯然，您在某個時候將再次需要現金來繼續資助臨床研究。但你有沒有想過這對你來說在時間上意味著什麼？

Well, like every development stage life science company that doesn't have its products approved for sale yet, we will need to continue to raise money, but hopefully, eventually with strategic partners rather than financial investors. But we'll see what the appetite is going forward. As you say, the India decision was far more about the potential delay in getting approval to move forward into the PMA phase than the savings, even though the savings are nice. That was not the main factor.

好吧，就像每一家產品尚未獲準銷售的發展階段生命科學公司一樣，我們需要繼續籌集資金，但希望最終能與戰略合作夥伴而不是金融投資者合作。但我們會看看未來的需求如何。正如你所說，印度的決定更多的是考慮到獲得進入 PMA 階段的批准可能會延遲，而不是為了節省成本，儘管節省成本是件好事。這不是主要因素。

And I must say, Marla, I was the driving force behind doing the Indian trial. The nephrologist has done a great job for us in the past, and they're great. But one advantage of India was that all of the previous viral trials we did. We got off the ground very quickly. They did a good job.

我必須說，瑪拉，我是進行印度試驗的推動者。腎臟科醫生過去為我們做了大量工作，他們很棒。但印度的一個優點是，我們之前進行過所有的病毒試驗。我們很快就起飛了。他們做得很好。

That's not the case anymore. They have many new regulations. They're much more like the FDA in terms of bureaucracy, and it was just far slower bureaucratically than the Australian trial. And it just didn't make sense to potentially hamstring the company for one to two years waiting for that trial to conclude. It just -- that put me over the edge with the decision.

現在情況已經不再如此了。他們有許多新規定。從官僚主義角度來說，他們更像 FDA，只是比澳洲的試驗慢得多。而且，等待審判結束可能會讓公司陷入一到兩年的困境，這根本毫無意義。這只是——這讓我在做決定時感到很為難。

I get it. That makes sense to me. And also, you've talked in the past about one of the attractive factors about conducting clinical research in Australia is the cash tax rebate. I don't think there was any similar -- I mean, I think expenses are relative to conducting research here in the US, costs would have been lower in India, but there wasn't anything comparable in terms of a rebate.

我得到它。我覺得很有道理。而且，您過去曾談到，在澳洲進行臨床研究的吸引力之一就是現金退稅。我認為沒有任何相似之處——我的意思是，我認為費用是相對於在美國進行研究而言的，在印度的成本會更低，但在回扣方面沒有任何可比性。

You are correct. We have that nice tax rebate in Australia. I think it's still 43% or thereabouts. I don't believe it's changed. And there's no rebate like that in India. So while the cost would have been lower by the hospital, I'm not sure, it might have even pencil lower in Australia after factoring in the rebate.

你是對的。我們在澳洲有很好的退稅政策。我認為仍然是43%左右。我不相信它已經改變。而在印度則沒有這樣的折扣。因此，雖然醫院的費用可能會更低，但我不確定，但如果考慮到退款，澳洲的費用可能會更低。

Okay, thank you.

好的，謝謝。

Thank you, Marla.

謝謝你，瑪拉。

RK, H.C. Wainwright.

RK，H.C.溫賴特。

Thank you. Good afternoon. I have a couple of questions. The first question regarding the Indian trial itself. I'm just trying to understand what was the reason to having set up -- in the first place, setting up a parallel Indian trial as that was going on in Australia.

謝謝。午安.我有幾個問題。第一個問題是關於印度審判本身的。我只是想知道設立該審判的理由是什麼——首先，設立一個與澳洲正在進行的印度平行的審判。

And the second question is, does -- do you think -- I know the first cohort is done and one of the physician scientists is actually doing analysis with regards to -- I'm assuming the extra vesicular -- the efficacy itself is what he or she is looking for. But have you -- or do you think you can speed up the enrollment in those three centers? Or are you trying to get additional centers in Australia so that you can add more patients if you wanted a larger data set to make the decision for the next development stage.

第二個問題是，您是否認為——我知道第一批研究已經完成，其中一位醫師科學家實際上正在進行分析——我假設是囊泡外——療效本身就是他或她所尋求的。但是您認為您可以加快這三個中心的招生速度嗎？或者您是否想在澳洲建立更多中心，以便您可以新增更多患者，如果您想要更大的資料集來為下一個開發階段做出決策。

Steve, do you want to reply?

史蒂夫，你想回覆嗎？

Sure. So first, on the EV and T cell data, we've actually accelerated the time lines to try to get data back from the Grau lab quicker, and they have been very responsive. So like I said, I'm hopeful that there'll be some early data in September. To your second question, we're doing multiple efforts to try to speed things up. One is we're following prescreening logs from all three active sites.

當然。首先，關於 EV 和 T 細胞數據，我們實際上加快了時間表，試圖更快地從 Grau 實驗室獲取數據，而且他們的反應非常迅速。所以就像我說的，我希望九月能有一些早期數據。對於您的第二個問題，我們正在採取多種措施來加快進程。一是我們正在追蹤所有三個活躍站點的預篩選日誌。

We're keeping in close contact through our CRO with our activity. We are actively recruiting plans for two additional sites, again, to augment enrollment. And three, we are looking at a couple of different types of initiatives.

我們透過 CRO 與我們的活動保持密切聯繫。我們正在積極招募另外兩個站點的計劃，以再次增加招生人數。第三，我們正在研究幾種不同類型的措施。

To help enrollment. one is the use of what's called clinical trial liaisons. The other is with social media campaigns. So yes, we are actively turning over every rock to look for ways to speed up enrollment and think that those will pay dividends.

為了幫助招生，一種方法是使用所謂的臨床試驗聯絡員。另一個是社群媒體活動。所以是的，我們正在積極地想辦法尋找加快招生速度的方法，並認為這些方法會帶來回報。

Okay. Thank you for that. So do you think when the Grau lab gets done with the analysis, will you be able to put out some sort of press release or talk about it? Or do you need to wait for the -- all the three cohorts to be done before you start talking about some of that efficacy data.

好的。謝謝你。那麼您認為當 Grau 實驗室完成分析後，您是否能夠發布某種新聞稿或談論它？或者您是否需要等待所有三個隊列都完成後再開始談論一些功效數據。

Well, so my feeling is we will have -- we'll be able to make some observations from this first cohort. But remember, it's only a single HP treatment. And we do not know -- that's why the dose-finding component is part of it. We don't know if you need one, two or three. So the trial, the jury really won't be out on the dosing until we're done with all three cohorts.

嗯，我的感覺是，我們將能夠從第一批人身上做出一些觀察。但請記住，這只是一次 HP 治療。而我們不知道——這就是為什麼劑量探索部分是其中的一部分。我們不知道您需要一個、兩個還是三個。因此，在我們對所有三個群體進行審判之前，陪審團實際上不會對劑量做出最終決定。

So again, we'll be able to make some observations, but I want to -- I truly want to see what the dose response is, what the treatment effects are from each individual cohort.

所以，我們可以再次進行一些觀察，但我想——我真正想看看劑量反應是什麼，每個個體群體的治療效果是什麼。

As Steve noted in his remarks, RK, our current expectation is that we'll be able to present those remarks or observations rather in September.

正如史蒂夫在演講中指出的那樣，RK，我們目前的期望是，我們將能夠在 9 月提出這些演講或意見。

Okay, no, that's great. Thank you.

好的，不，那太好了。謝謝。

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

我想再次感謝您今天加入我們討論我們的第一財季業績。我們期待向您通報未來通話的最新情況。再次感謝。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。