에슬론 메디컬(AEMD) 2027 회계연도 1분기 실적 발표 콘퍼런스 콜: 종양학 임상시험 최종 코호트 진입

핵심 요약

• 에슬론 메디컬(NASDAQ: AEMD)은 2027 회계연도 1분기 영업비용이 약 160만 달러로 전년 동기 180만 달러 대비 11.9% 감소했다고 발표했습니다.
• 2026년 6월 30일 기준 현금 및 현금성 자산은 약 490만 달러였습니다. 분기 종료 후, 회사는 유상증자를 통해 약 400만 달러의 총 공모 금액을 조달했습니다.
• 경영진은 기존 계획에 기반해 현재 현금 자원이 최소 향후 12개월 동안의 운영 자금을 충당하기에 충분하다고 판단하고 있습니다.
• 호주 암 임상시험이 세 번째이자 마지막 코호트에 진입했습니다. 첫 번째 참가자는 기기 관련 중대한 이상사례나 용량 제한 독성 없이 4시간 동안의 헤모퓨리파이어 치료 3회 및 8주간의 추적 관찰을 완료했습니다.
• 안전성 문제가 발생하지 않는다고 가정할 때, 임상시험을 완료하려면 추가로 2명의 참가자를 치료해야 합니다. 경영진은 2026년 말 또는 2027년 초까지 치료 및 추적 관찰을 완료하는 것을 목표로 하고 있습니다.
• 코호트 2의 예비 관찰 결과, 종양 유래 세포외 소포체를 포함한 전체 세포외 소포체와 암 진행 관련 미세RNA가 감소한 것으로 나타났습니다. 회사 측은 이러한 결과가 제한된 원시 데이터에 근거한 것이며 정식 통계 분석을 거치지 않았다고 강조했습니다.

주요 재무 데이터

영업비용 감소는 전문 서비스 수수료, 일반관리비, 전임상 연구비의 감소를 반영한 것입니다. 경영진은 이에 따라 영업손실도 줄어들었다고 밝혔습니다.

사업 및 영업 성과

헤모퓨리파이어는 여전히 연구용 기기 단계에 있습니다. 에슬론 메디컬의 호주 암 임상시험은 3개 코호트에 걸쳐 단계적으로 더 집약적인 치료 일정을 평가합니다.

코호트 1 참가자는 4시간 치료 1회를 받았고, 코호트 2 참가자는 1주일 동안 4시간 치료 2회를 받았습니다. 경영진은 코호트 2 원시 데이터를 검토한 결과, 코호트 1에 비해 참가자 전반에 걸쳐 더 일관된 바이오마커 변화와 더 오래 지속되는 긍정적 방향의 변화가 확인되었으며, 일부 경우 8주 측정 시점까지 지속되었다고 말했습니다.

세 번째 코호트는 1주일 동안 4시간 치료 3회를 실시합니다. 실적 발표 시점 기준으로 첫 번째 참가자의 실험실 결과는 아직 나오지 않았습니다. 정식 통계 분석 및 용량 반응 분석은 임상시험이 완료된 후 진행될 예정입니다.

에슬론 메디컬은 암 분야 외에도 헤모퓨리파이어의 적용 범위를 평가하고 있습니다. 2026년 6월 25일에 발표된 연구에 따르면 롱코비드 환자의 혈장 검체에 있는 소형 및 대형 세포외 소포체가 헤모퓨리파이어의 자체 친화성 수지에 결합한 것으로 나타났습니다. 또한 해당 수지에 대한 노출은 면역 조절 장애 및 염증과 관련된 미세RNA 수준 감소와 관련이 있었습니다.

회사는 학술 기관 및 규제 기관과 롱코비드 임상 개발 추진 방안을 논의할 계획입니다. 연구소에서는 만성 콩팥병 환자의 루푸스 및 심장 질환에 관여하는 세포외 소포체를 별도로 연구하고 있습니다.

경영진 가이드언스

경영진의 목표는 2026년 말 또는 2027년 초까지 호주 암 임상시험의 남은 헤모퓨리파이어 치료와 8주간의 추적 관찰을 완료하는 것입니다. 그 다음 단계로는 데이터 분석, 임상시험 보고서 작성, 규제 기관과의 등록 전 임상 논의 등이 포함될 예정입니다.

경영진은 코호트 3에서 코호트 2에서 관찰된 바이오마커 패턴이 뒷받침될 경우, 주 3회 치료 일정을 향후 효능 연구로 이어갈 수 있다고 말했습니다. 다만 해당 결정은 최종 완성된 데이터 세트에 따라 달라질 수 있습니다.

리스크 및 주요 점검 사항

• 바이오마커 관련 결과는 예비 단계로 소수의 참가자만을 대상으로 한 것이며, 안전성, 유효성 또는 임상적 이점에 대한 증거로 해석되어서는 안 됩니다.
• 코호트 간 비교는 현재 기준선 대비 백분율 변화나 정식 통계 검정이 아닌 원시 관찰 데이터에 기반하고 있습니다.
• 기기 관련 중대한 이상사례나 용량 제한 독성이 발생하지 않는다는 전제하에, 임상시험을 완료하기 위해서는 여전히 추가로 2명의 참가자가 필요합니다.
• 각 세션마다 준비 및 분리 시간이 필요해 환자가 거의 하루 전체를 투입해야 하므로, 경영진은 주 3회(회당 4시간)를 초과하는 치료 일정은 비현실적이라고 판단하고 있습니다.
• 추가 적응증을 임상시험 단계로 진척시키기 위해서는 새로운 자금 조달, 파트너십, 정부 보조금 또는 기타 자금 출처가 필요할 가능성이 높습니다.
• 롱코비드에 대한 규제 승인 경로는 여전히 불확실합니다. 회사가 보유한 기존 혁신 의료기기 지정은 생명을 위협하는 바이러스를 대상으로 하고 있으며, 경영진은 롱코비드가 현재 여기에 포함되어 있지 않다고 설명했습니다.

애널리스트 Q&A 주요 내용

경영진은 코호트 1의 경우 참가자 3명 중 대략 2명에게서 바이오마커 변화가 나타났으며, 이는 일반적으로 2~3주간 지속되었다고 설명했습니다. 코호트 2에서는 원시 신호가 참가자 전반에 걸쳐 더 일관되게 나타났고, 일부 방향성 변화는 8주 동안 지속되었습니다. 코호트 3은 치료 빈도가 바이오마커 변화의 크기나 지속 기간과 관련이 있는지 여부를 결정하는 데 중요한 역할을 할 것입니다.

회사는 현재 주 4회 치료를 테스트할 계획이 없습니다. 경영진은 월·수·금 형태의 일정으로 진행되는 회당 4시간의 주 3회 세션이 환자의 내약성과 물류 측면에서 실질적인 상한선이라고 보고 있습니다.

헤모퓨리파이어의 보다 광범위한 적용과 관련하여, 에슬론 메디컬은 연구원, 장비, 시약 및 외부에서 조달한 검체를 활용해 저비용 자체 연구를 계속 이어갈 것으로 예상됩니다. 경영진은 결과 데이터 및 논문 발표를 통해 파트너십 기회가 창출될 수 있다고 언급했으나, 어떠한 거래나 규제 적응증 확장도 확약된 것은 없다고 밝혔습니다.

실적 발표 전화회의 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

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.

질의응답

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.