Aethlon Medical (AEMD) 2027 財年第一季財報電話會議：腫瘤試驗進入最後一個受試者群組

重點摘要

• Aethlon Medical (NASDAQ: AEMD) 公布 2027 財年第一季營業費用約為 160 萬美元，較去年同期的 180 萬美元下降 11.9%。
• 截至 2026 年 6 月 30 日，現金及現金等價物總計約為 490 萬美元。季度結束後，該公司透過公開股票發行募得約 400 萬美元的總收益。
• 管理層認為，根據現有計劃，目前的現金資源足以支持未來至少 12 個月的營運。
• 澳洲的腫瘤學研究已進入第三個也是最後一個世代（cohort）。首位受試者完成了三次四小時的 Hemopurifier 治療及為期八週的追蹤，未出現與醫療器材相關的嚴重不良事件或劑量限制性毒性。
• 在不發生符合條件的安全性事件的前提下，仍需對另外兩名受試者進行治療才能完成研究。管理層的目標是在 2026 年底或 2027 年初前完成治療與追蹤。
• 第二世代的初步觀察顯示，總細胞外囊泡（包含腫瘤來源的細胞外囊泡）以及與癌症進展相關的微小 RNA（microRNA）均有所減少。公司強調，這些發現是基於有限的原始資料，尚未經過正式的統計分析。

關鍵財務數據

營業費用的減少反映了專業服務費、一般及行政費用以及臨床前研究成本的下降。管理層亦表示，營業虧損也相應減少。

業務與營運表現

Hemopurifier 仍屬於實驗性醫療器材。Aethlon Medical 在澳洲進行的腫瘤學試驗分三個世代評估強度逐漸增加的治療時程。

第一世代受試者接受了一次四小時的治療，而第二世代受試者則在一週內接受了兩次四小時的治療。管理層表示，對第二世代原始資料的檢視顯示，受試者之間的生物標記變化更趨一致，且正向趨勢的持續時間比第一世代更長，在某些情況下甚至延伸至八週的測量時間點。

第三世代則在一週內進行三次四小時的治療。在電話會議時，首位受試者的實驗室結果尚未出爐。正式的統計分析與劑量反應分析將在試驗完成後進行。

Aethlon Medical 也在評估 Hemopurifier 在腫瘤學之外的應用。2026 年 6 月 25 日發表的研究指出，長新冠（long COVID）患者血漿樣本中的小型及大型細胞外囊泡會與 Hemopurifier 專利的親和樹脂結合。接觸該樹脂亦與免疫調節失調及發炎相關的微小 RNA 水準下降有關。

該公司計劃與學術機構和監管機構討論長新冠臨床開發的可能路徑。其實驗室正在另行研究慢性腎臟病患者中與紅斑性狼瘡及心臟病相關的細胞外囊泡。

管理層指引

管理層的目標是在 2026 年底或 2027 年初前完成澳洲腫瘤學試驗剩餘的 Hemopurifier 治療與八週追蹤。隨後的步驟將包括資料分析、完成臨床研究報告，以及與監管機構進行註冊前試驗的討論。

管理層表示，如果第三世代能支持第二世代中所觀察到的生物標記模式，每週三次治療的時程可能會延續至未來的療效研究中。該決定仍將視完整資料集而定。

風險與關注焦點

• 生物標記的發現屬於初步結果，涉及的受試者人數有限，不應被解讀為安全性、有效性或臨床效益的證明。
• 目前世代間的比較是基於原始觀察結果，而非相較於基準線的百分比變化或正式的統計檢定。
• 該試驗仍需要另外兩名受試者，前提是沒有發生與醫療器材相關的嚴重不良事件或劑量限制性毒性。
• 管理層認為每週超過三次、每次四小時的治療時程並不切實際，因為每次治療都需要準備與拆卸時間，對患者而言幾乎是一整天的負擔。
• 將其他疾病適應症推進至臨床試驗階段，可能需要新的資金、合作夥伴、政府補助或其他資金來源。
• 長新冠的監管路徑仍不確定。該公司現有的突破性醫療器材認定範圍涵蓋危及生命的病毒，但管理層表示長新冠目前並未納入其中。

分析師問答環節重點

管理層澄清，第一世代在約三分之二的受試者中顯示出生物標記變化，通常持續二至三週。在第二世代中，受試者之間的原始訊號顯得更加一致，部分趨勢變化持續長達八週。第三世代對於確定治療頻率是否與生物標記變化的程度或持續時間更大相關至關重要。

該公司目前沒有計劃測試每週四次治療。管理層認為按照週一、週三、週五方式安排的三次四小時治療，是患者耐受度與後勤安排上的實質上限。

關於 Hemopurifier 更廣泛的應用，Aethlon Medical 預計將利用其科學家、設備、試劑及外部取得的樣本，繼續進行低成本的內部研究。管理層表示，所得數據和發表的論文可能會創造合作機會，但並未承諾任何交易或監管擴展。

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完整財報電話會議逐字稿

管理層陳述

Operator

Good day, and welcome to the Aethlon Medical First Quarter Fiscal 2027 Earnings and Corporate Update Conference Call. [Operator Instructions] Please note this event is being recorded.

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

James Frakes

Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's First Fiscal Quarter ended June 30, 2026 Earnings Conference Call. My name is Jim Frakes, and I'm the Chief Executive Officer and Chief Financial Officer of Athlon Medical. At 4:15 p.m. Eastern Time today, Athlon Medical released financial results for its first fiscal quarter ended June 30, 2026.

If you have not seen or received Aethlon Medical's earnings release, please visit the Investors page at athlonmedical.com to view it. Following this introduction and the reading of the company's forward-looking statement disclaimer, Dr. Stephen 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.

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 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.

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. I'd like to begin by highlighting progress during the first fiscal quarter ended June 30, 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 chemo purifier applications into additional disease areas through preclinical research.

As Steve will discuss, we are now in the final cohort of our oncology trial. We continue to generate encouraging preliminary biomarker observations, and we are expanding our research into potential applications beyond oncology. Taken together, we believe these achievements demonstrate continued execution against our key priorities of clinical development, platform expansion, intellectual property growth and disciplined resource management.

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

Steven Larosa

Thank you, Jim. Before discussing our clinical observation, I want to emphasize that the Hemopurifier remains an investigational device. Any biomarker observations discussed today are preliminary and are based on the limited number of participants and should not be interpreted as evidence of safety or effectiveness or clinical benefit. The first participated in our third and final cohort of our Australian oncology trial has been enrolled and treated. .

This participant received 3 4-hour HemoCue treatments over the course of a 1-week period. The participant is now 2 months into the follow-up period and has not experienced any device-related serious adverse events or dose-limiting consistency. We need to only treat 2 additional participants to complete the trial, provided that none of the future participants develop any of these safety events. The 3 investigative sites remain engaged and are actively prescreening potential participants. Our goal remains to complete all HP treatments and the 8-week follow-up central lab measurement period by the end of this year 2020. The next steps would the analysis of the data.

Clinical study report completion and preregistration clinical trial discussion with regulatory parties Central lab measurements of extracellular vesicles microRNAs and lymphocyte subsets have been completed by the University of Sydney on the samples from cohort 2 of the clinical trial, where participants received 2 4-hour chemopurified treatments over the course of 1 week. A review of the raw data has taken place. As stated in the press release on July 13, 2026. We continue to see decreases in total extracellular vesicle comps including tumor-derived to cellular vesicles, and microRNA linked to cancer progression following the HB treatment.

Additionally, we observed increases in lipid success as well as positive directional changes and laboratory permit ratios that have been associated with responses to immunotherapy. The changes appear to be more consistent across participants and persisted for longer in cohort 2 compared with cohort 1, where participants received a single hemophurifiine treatment, independent formal statistical analysis, including a dose response analysis will be performed upon completion of the trial. Segue now to preclinical R&D activities. Our prior work in Long cove was published in the Preview Journal International Journal of Molecular Sciences on the 25 June 2026.

In this publication, we present data demonstrating that both small and large EV extractor vesicles in noncoded patient plasma samples bind to the proprietary G&A affinity resin within our Athlon Hemopurifier. Furthermore, following exposure of the patient plasma to the resin, a decrease in microRNAs associated with immune disregulation and inflammation was observed.

This data, coupled with the data from an outside group demonstrating the presence of the COVID spike protein and protein associated with inflammation and amoral clotting within the EVs of long cover patients, raises the possibility of EV removal as a potential parametal therapeutic strategy and Ronco. We plan discussions with academic institutions as well as regulatory agencies to see if there's a clinical development path forward or if additional preclinical work will be necessary. Finally, our lab continues to perform experiments exploring the ability of the Hemopurifier technology to bind to remove EVs implicated in other diseases, such as lupus and heart disease in those with chronic kidney disease.

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

James Frakes

Thanks, Steve, and good afternoon, again, everyone. Let me turn briefly to our financial position and our focus on disciplined spending. At June 30, 2026, a we have approximately $4.9 million in cash and cash equivalents, providing resources to support ongoing clinical and research activities. Subsequent to quarter end, we further strengthened our balance sheet by raising approximately $4 million in gross proceeds through a public offering of common stock. Based on current plans, we believe our cash resources are sufficient to fund operations for at least the next 12 months.

Our consolidated operating expenses for the quarter decreased 11.9% and to approximately $1.6 million compared with $1.8 million in the prior year quarter. That decrease was driven by lower professional fees and reduced general and administrative and preclinical research costs and our operating loss declined accordingly. You will find additional 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, 2026 and March 31, 2026.

The and the consolidated statements of operations for the fiscal quarters ended June 30, 2026 and 2025. We will file our quarterly report on Form 10-Q following this call. Our next earnings call for the fiscal second quarter ending September 30, 2026, will coincide with the filing of our quarterly report on Form 10-Q in November 2026, and now we would be happy to answer any questions that you may have. Operator, please open the call for questions.

Operator

[Operator Instructions]

The first question today comes from Marla Marin with Zacks.

分析師問答

Marla Marin

So I want to go back to something, Steve, that you said in your prepared remarks. I want to make sure that I understood. So the 3 different cohorts of the Australia study, increase dosage, increase treatment with the hemopuriapier. And I think what you said was currently, even though it's early in terms of a full data set, you're thinking that Phase II participants exhibit a longer benefit than those who participated in Phase 1. Is that the right way to think about what your comments were .

Steven Larosa

Right. So in cohort 1, the participants received only a single 4-hour HP treatment in Cohort 2, they received to 4-hour treatment. So cohort 1 would be like on Friday 4 hours, whereas Cohort 2 would be Monday and Friday for 4 hours. All cohorts within had samples done before and after the Hemopurifier treatments and then weekly in the follow-up period for 4 weeks, so week 1, 2, 3, and 4 and 8. And we looked at EVs, T cells as well as microRNAs over the course of all those time points. When you look at the raw data, and again, this is based purely on observations of the raw data, this is now looking at change from baseline, percent change from baseline or formal statistical out.

If you look purely at the raw data, typically in Cohort 1, we were seeing changes in 2 out of 3 participants where in Cohort 2, we tended to see it more consistent across participants. And then if you look at the positive directional change in those parameters, where in Cohort 1, you see those changes go out, say, 2, 3 weeks. We're seeing more times in Cohort 2 where we're seeing the positive directional change go out as far as the 8-week time period. So at least what I can say is it looks like the biologic signal is more consistent across 3 participants in Cohort 2.

And then it seems the positive directional change seems to last long. So it really cohort 3 will follow the tail if we continue to see that kind of increased magnitude and change as well as duration of change that will tell us that what we've seen to date is real, but encourage nonetheless, by at least the signal and the raw data that we're seeing.

Marla Marin

Got it. Got it. And you can't really comment yet on Cohort 3 because it's so early, correct?

Steven Larosa

Yes. We don't have any result. The first patient is like I said, just finish their 2-month or their 8-week follow-up period. So we don't have any data back yet on that patient in terms of the oral .

Marla Marin

But let's say that the trajectory continues along the same lines, as you just described in Cohort 3 participants show an even longer duration of improvement and more consistent across the participants. -- would there be a reason to think that you should -- when you -- if and when you go forward and design the next set of research parameters, would there make any sense to design a cohort that gets 4 treatments weekly? Or you think that the retreatment .

Steven Larosa

I think it's an excellent question. The thing you start running up against this tolerability and feasibility. So what we thought based on clinical medicine. And then we're drawing on the experience in hemodialysis mostly that anything more than 4 hours of treatment 3 times a week, say, a Monday, Wednesday, Friday, schedule this will not be tolerable to patients. That's about as much as the old tolerate. And so no, we're not considering going to 4 treatments that on .

Marla Marin

Okay. And that is not a function of the white Hemopurifier treatment is currently administered that could possibly change if you do move to a simplified treatment -- streamline treatment system. Is that correct? It's not -- it has nothing to do with the way you're treating people. It really is just having that treatment in and of itself probably cannot be tolerated more than 3 times a week. .

Steven Larosa

Yes, well tolerated both in terms of logistics and what patients themselves. I mean you talk about 4 hours, but there's also time in terms of hooking the patient up, timing the system taking them off. So it ends up being a complete day, it's not just 4 hours. So yes, anything more than 3 days. .

Again, and if we see in cohort 3, what we're seeing in Cohort 2 where we're seeing the directional changes we want, hopefully even greater magnitude with 3 treatments then we would take that 3 treatment in a week strategy forward for an efficacy trial. But they're kind of getting a little bit of ahead of ourselves, we have to see the data first. .

Marla Marin

Okay. One last question. So you mentioned also that there are many other conditions and diseases where EVs are indicated -- so you've been really good in the past. And Jim, I think that this is more of a question for you probably. You've been very good in the past at maintaining certain maintaining research on the Hemopurifier without incurring significant costs, not actual critical testing, but publishing papers speaking at medical conventions and other ways of trying to test the hypothesis that the Hemopurifier can be beneficial across the spectrum, of different indications.

Are there other opportunities do you think for doing more and broader work about the Hemopurifier in an extremely cost-effective way. .

James Frakes

Well, we can continue to do what we're doing, which is exactly as you described, Marla, using our in-house scientists, our in-house equipment, buying reagents and things, but that's not expensive. And trying to get samples either given to us or an extensively purchased. And we can continue to do that, continue to write articles -- but to really move forward, eventually, we would need to either bring in more capital to finance a clinical trial in 1 of these -- 1 or more of these diseases, to partner up with somebody, other government grants or 2 there are options out there and -- but I think we would need to support 1 of those ways to actually conduct a clinical trial in 1 of these things. So we will continue to do what we're doing. And try to find the right opportunities to move forward. .

Marla Marin

Okay. That's makes sense. But is it also fair to say that what you're doing, even though it's clear that you need to proceed to more structured clinical research -- is it fair to think that what you are doing gives you much more optionality in terms of finding a potential partner for certain or a variety of indications.

James Frakes

It's possible. We are talking to people. If another option is in future discussions with the FDA, if they chose to broaden or add to our breakthrough device designation in viruses.

Right now, it's just for life-threatening viruses, which long coba is not considered a life-threatening virus. But if they were to expand it to include that, then we could do potential emergency use the one-off treatments actually get some human data. But again, that's just a possibility. I'm not promising anything, but those options could happen.

Operator

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

James Frakes

Thank you. In closing, I'd like to recap some items to keep on your radar screens. First, we are now in the final cohort of our Australian oncology trial, with the goal of completing treatment and related follow-up by the end of calendar 2026 or early 2027. Second, the preliminary cohort 2 biomarker observations provide additional data for us to analyze as we complete the trial and move toward our next regulatory discussions. .

And third, as just discussed, we continue to explore the broader potential of the Hemopurifier platform, including in long COVID and in other diseases in which extracellular vesicles may play a role. We remain focused on advancing the Hemopurifier platform through disciplined clinical execution, rigorous analysis of our data and careful capital management. We appreciate your continued interest and support. Thank you for attending our call.

Operator

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