Aethlon Medical (AEMD) Ergebniskonferenz zum 1. Quartal des Geschäftsjahres 2027: Onkologie-Studie erreicht letzte Kohorte

Wichtigste Erkenntnisse

• Aethlon Medical (NASDAQ: AEMD) meldete für das erste Quartal des Geschäftsjahres 2027 operative Aufwendungen von rund 1,6 Millionen US-Dollar, was einem Rückgang von 11,9 % gegenüber 1,8 Millionen US-Dollar im Vorjahresquartal entspricht.
• Die liquiden Mittel beliefen sich zum 30. Juni 2026 auf rund 4,9 Millionen US-Dollar. Nach Quartalsende nahm das Unternehmen durch ein öffentliches Aktienangebot Bruttoerlöse von rund 4 Millionen US-Dollar ein.
• Das Management geht davon aus, dass die aktuellen liquiden Mittel auf Basis der bestehenden Pläne ausreichen, um den Geschäftsbetrieb für mindestens die nächsten 12 Monate zu finanzieren.
• Die australische Onkologie-Studie ist in ihre dritte und letzte Kohorte eingetreten. Der erste Teilnehmer absolvierte drei vierstündige Hemopurifier-Behandlungen sowie die achtwöchige Nachbeobachtung ohne ein gerätebedingtes schwerwiegendes unerwünschtes Ereignis oder eine dosislimitierende Toxizität.
• Zwei weitere Teilnehmer müssen noch behandelt werden, um die Studie abzuschließen, sofern keine relevanten Sicherheitsereignisse auftreten. Das Management strebt an, Behandlung und Nachbeobachtung bis Ende des Kalenderjahres 2026 oder Anfang 2027 abzuschließen.
• Vorläufige Beobachtungen in Kohorte 2 zeigten eine Verringerung der gesamten extrazellulären Vesikel, einschließlich von Tumoren stammender extrazellulärer Vesikel, sowie von microRNAs, die mit dem Fortschreiten von Krebserkrankungen in Verbindung gebracht werden. Das Unternehmen betonte, dass diese Ergebnisse auf begrenzten Rohdaten beruhen und noch keiner formalen statistischen Analyse unterzogen wurden.

Wichtige Finanzdaten

Der Rückgang der operativen Aufwendungen war auf geringere Honorare für Beratungsdienstleistungen, niedrigere Allgemeine- und Verwaltungskosten sowie gesunkene präklinische Forschungskosten zurückzuführen. Das Management gab zudem an, dass sich der Betriebsverlust entsprechend verringert hat.

Geschäfts- und operative Entwicklung

Der Hemopurifier befindet sich weiterhin in der klinischen Erprobung. Die australische Onkologie-Studie von Aethlon Medical untersucht schrittweise intensivere Behandlungspläne über drei Kohorten hinweg.

Die Teilnehmer der Kohorte 1 erhielten eine vierstündige Behandlung, während die Teilnehmer der Kohorte 2 zwei vierstündige Behandlungen im Laufe einer Woche erhielten. Laut Management zeigte die Überprüfung der Rohdaten aus Kohorte 2 konsistentere Biomarker-Veränderungen bei allen Teilnehmern und länger anhaltende positive Richtungstrends als in Kohorte 1, die sich in einigen Fällen bis zum achtwöchigen Messzeitpunkt erstreckten.

Die dritte Kohorte wendet drei vierstündige Behandlungen im Laufe einer Woche an. Zum Zeitpunkt der Telefonkonferenz lagen für den ersten Teilnehmer noch keine Laborergebnisse vor. Formale statistische Analysen sowie Dosis-Wirkungs-Analysen werden nach Abschluss der Studie durchgeführt.

Aethlon Medical prüft zudem Einsatzmöglichkeiten des Hemopurifiers außerhalb der Onkologie. Eine am 25. Juni 2026 veröffentlichte Studie berichtete, dass kleine und große extrazelluläre Vesikel in Plasmaproben von Patienten mit Long COVID an das proprietäre Affinitätsharz des Hemopurifiers bunden. Die Exposition gegenüber dem Harz war zudem mit geringeren Konzentrationen von microRNAs verbunden, die mit Immunfehlregulationen und Entzündungen in Zusammenhang stehen.

Das Unternehmen plant, einen möglichen klinischen Entwicklungspfad für Long COVID mit akademischen Institutionen und Regulierungsbehörden zu erörtern. In seinem Labor untersucht das Unternehmen unabhängig davon extrazelluläre Vesikel, die mit Lupus und Herzerkrankungen bei Patienten mit chronischer Nierenerkrankung in Verbindung gebracht werden.

Prognose des Managements

Ziel des Managements ist es, die verbleibenden Hemopurifier-Behandlungen der australischen Onkologie-Studie sowie die achtwöchige Nachbeobachtung bis Ende des Kalenderjahres 2026 oder Anfang 2027 abzuschließen. Zu den anschließenden Schritten gehören die Datenanalyse, die Fertigstellung des klinischen Studienberichts sowie Gespräche über Zulassungsstudien mit den Regulierungsbehörden.

Sollte Kohorte 3 die in Kohorte 2 beobachteten Biomarker-Muster bestätigen, könnte laut Management ein Behandlungsplan mit drei Sitzungen pro Woche in eine künftige Wirksamkeitsstudie übernommen werden. Diese Entscheidung bleibt jedoch vom vollständigen Datensatz abhängig.

Risiken und wichtige Beobachtungspunkte

• Ergebnisse zu Biomarkern sind vorläufig, betreffen eine begrenzte Anzahl von Teilnehmern und sollten nicht als Nachweis für Sicherheit, Wirksamkeit oder klinischen Nutzen interpretiert werden.
• Vergleiche zwischen den Kohorten basieren derzeit auf Rohbeobachtungen und nicht auf prozentualen Veränderungen gegenüber dem Ausgangswert oder formalen statistischen Tests.
• Für die Studie werden noch zwei weitere Teilnehmer benötigt, sofern keine gerätebedingten schwerwiegenden unerwünschten Ereignisse oder dosislimitierenden Toxizitäten auftreten.
• Das Management hält Behandlungspläne mit mehr als drei vierstündigen Sitzungen pro Woche für unpraktikabel, da jede Sitzung zusätzlich Zeit für Auf- und Abbau erfordert, was für die Patienten nahezu einen ganztägigen Zeitaufwand bedeutet.
• Der Übergang weiterer Indikationen in klinische Studien würde voraussichtlich frisches Kapital, einen Partner, staatliche Fördergelder oder eine andere Finanzierungsquelle erfordern.
• Der regulatorische Weg für Long COVID bleibt ungewiss. Der bestehende Status als Durchbruchtechnologie (Breakthrough Device Designation) des Unternehmens deckt lebensbedrohliche Viren ab, während Long COVID laut Management derzeit nicht darin enthalten ist.

Highlights der Fragerunde mit Analysten

Das Management stellte klar, dass Kohorte 1 bei etwa zwei von drei Teilnehmern Biomarker-Veränderungen zeigte, die im Allgemeinen zwei bis drei Wochen anhielten. In Kohorte 2 erschien das Rohsignal bei allen Teilnehmern konsistenter, wobei sich einige Richtungsänderungen über acht Wochen hinweg fortsetzten. Kohorte 3 wird wichtig sein, um festzustellen, ob die Behandlungsfrequenz mit einem größeren Ausmaß oder einer längeren Dauer der Biomarker-Veränderungen einhergeht.

Das Unternehmen plant derzeit nicht, vier Behandlungen pro Woche zu testen. Das Management sieht drei vierstündige Sitzungen nach einem Schema wie Montag-Mittwoch-Freitag als praktische Obergrenze für Verträglichkeit und Logistik der Patienten an.

Bezüglich breiterer Anwendungsmöglichkeiten des Hemopurifiers geht Aethlon Medical davon aus, kostengünstige interne Forschungen unter Nutzung eigener Wissenschaftler, Ausrüstungen, Reagenzien und extern bezogener Proben fortzusetzen. Das Management erklärte, dass die resultierenden Daten und Publikationen Partnerschaftsoptionen schaffen könnten, wenngleich weder eine Transaktion noch eine Erweiterung des regulatorischen Rahmens zugesagt wurden.

Vollständiges Transkript der Telefonkonferenz zu den Quartalsergebnissen

Vollständiges Transkript der Telefonkonferenz

Ausführungen des Managements

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.

Fragen und Antworten

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.