Llamada de resultados del primer trimestre fiscal de 2027 de Aethlon Medical (AEMD): el ensayo oncológico entra en la cohorte final

Puntos clave

• Aethlon Medical (NASDAQ: AEMD) informó que los gastos operativos del primer trimestre de su año fiscal 2027 fueron de aproximadamente 1,6 millones de dólares, lo que supone un descenso del 11,9% con respecto a los 1,8 millones de dólares del mismo periodo del año anterior.
• El efectivo y los equivalentes de efectivo sumaban aproximadamente 4,9 millones de dólares al 30 de junio de 2026. Tras el cierre del trimestre, la empresa captó aproximadamente 4 millones de dólares en ingresos brutos mediante una oferta pública de acciones.
• La dirección considera que los recursos de efectivo actuales son suficientes para financiar las operaciones durante al menos los próximos 12 meses, según los planes existentes.
• El estudio de oncología en Australia ha entrado en su tercera y última cohorte. El primer participante completó tres tratamientos con Hemopurifier de cuatro horas y el seguimiento de ocho semanas sin registrar ningún acontecimiento adverso grave relacionado con el dispositivo ni toxicidad limitante de la dosis.
• Se debe tratar a dos participantes adicionales para completar el estudio, asumiendo que no se produzcan eventos de seguridad determinantes. La dirección prevé finalizar el tratamiento y el seguimiento a finales del año natural 2026 o principios de 2027.
• Las observaciones preliminares de la cohorte 2 mostraron reducciones en las vesículas extracelulares totales, incluidas las vesículas extracelulares derivadas de tumores, y en los microARN vinculados a la progresión del cáncer. La empresa subrayó que estos hallazgos se basan en datos brutos limitados y no se han sometido a un análisis estadístico formal.

Datos financieros clave

El descenso de los gastos operativos reflejó menores honorarios profesionales, gastos generales y administrativos y costes de investigación preclínica. La dirección también señaló que la pérdida operativa se redujo en consonancia.

Rendimiento empresarial y operativo

El Hemopurifier sigue siendo un dispositivo en fase de investigación. El ensayo de oncología de Aethlon Medical en Australia evalúa pautas de tratamiento progresivamente más intensivas a lo largo de tres cohortes.

Los participantes de la cohorte 1 recibieron un tratamiento de cuatro horas, mientras que los de la cohorte 2 recibieron dos tratamientos de cuatro horas durante una semana. La dirección afirmó que su revisión de los datos brutos de la cohorte 2 indicó cambios de biomarcadores más consistentes entre los participantes y cambios direccionales positivos más duraderos que en la cohorte 1, extendiéndose en algunos casos hasta el punto de medición de las ocho semanas.

La tercera cohorte aplica tres tratamientos de cuatro horas durante una semana. En el momento de la conferencia telefónica, aún no se disponía de los resultados de laboratorio de su primer participante. Los análisis estadísticos formales y de dosis-respuesta se llevarán a cabo una vez concluido el ensayo.

Aethlon Medical también está evaluando aplicaciones de Hemopurifier más allá de la oncología. Una investigación publicada el 25 de junio de 2026 informó que las vesículas extracelulares pequeñas y grandes en muestras de plasma de pacientes con COVID persistente se unieron a la resina de afinidad patentada de Hemopurifier. La exposición a la resina también se asoció con niveles más bajos de microARN vinculados a la desregulación inmunitaria y la inflamación.

La empresa planea debatir una posible vía de desarrollo clínico para el COVID persistente con instituciones académicas y agencias reguladoras. Por otra parte, su laboratorio está estudiando vesículas extracelulares implicadas en el lupus y las enfermedades cardíacas en pacientes con enfermedad renal crónica.

Previsiones de la dirección

El objetivo de la dirección es completar los tratamientos restantes con Hemopurifier y el seguimiento de ocho semanas del ensayo de oncología en Australia a finales del año natural 2026 o principios de 2027. Los pasos posteriores incluirían el análisis de datos, la finalización del informe del estudio clínico y conversaciones con los organismos reguladores previas al ensayo de registro.

Si la cohorte 3 confirma los patrones de biomarcadores observados en la cohorte 2, la dirección señaló que la pauta de tres tratamientos por semana podría trasladarse a un futuro estudio de eficacia. Esa decisión sigue condicionada al conjunto final de datos.

Riesgos y aspectos a vigilar

• Los hallazgos de biomarcadores son preliminares, involucran a un número limitado de participantes y no deben interpretarse como evidencia de seguridad, eficacia o beneficio clínico.
• Actualmente, las comparaciones entre cohortes se basan en observaciones brutas más que en cambios porcentuales respecto al nivel de referencia o en pruebas estadísticas formales.
• El ensayo aún requiere dos participantes adicionales, siempre que no se produzcan acontecimientos adversos graves relacionados con el dispositivo ni toxicidades limitantes de la dosis.
• La dirección considera poco prácticas las pautas de tratamiento que superen las tres sesiones de cuatro horas a la semana, ya que cada sesión también requiere tiempo de preparación y desconexión, lo que supone casi un día entero de dedicación para los pacientes.
• Avanzar en indicaciones de otras enfermedades hacia ensayos clínicos requeriría probablemente nuevo capital, un socio, subvenciones gubernamentales u otra fuente de financiación.
• La vía regulatoria para el COVID persistente sigue siendo incierta. La designación existente de la empresa como dispositivo innovador cubre virus potencialmente mortales, mientras que la dirección indicó que el COVID persistente no está incluido actualmente.

Puntos destacados de la sesión de preguntas y respuestas con analistas

La dirección aclaró que la cohorte 1 mostró cambios en los biomarcadores en aproximadamente dos de cada tres participantes, que generalmente duraron de dos a tres semanas. En la cohorte 2, la señal bruta pareció más consistente entre los participantes, y algunos cambios direccionales se mantuvieron a lo largo de ocho semanas. La cohorte 3 será importante para determinar si la frecuencia del tratamiento está asociada a una mayor magnitud o duración de los cambios en los biomarcadores.

En la actualidad, la empresa no contempla probar cuatro tratamientos por semana. La dirección considera que tres sesiones de cuatro horas en una pauta de tipo lunes, miércoles y viernes representan el límite práctico superior para la logística y la tolerabilidad del paciente.

En cuanto a aplicaciones más amplias de Hemopurifier, Aethlon Medical prevé continuar con investigaciones internas de bajo coste utilizando sus propios científicos, equipos, reactivos y muestras de origen externo. La dirección señaló que los datos y publicaciones resultantes podrían generar opciones de colaboración, aunque no se prometió ninguna transacción ni expansión regulatoria.

Transcripción completa de la llamada de resultados

Transcripción completa de la conferencia de resultados

Comentarios de la dirección

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.

Preguntas y respuestas

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.