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AEMD

Aethlon MedicalD
Nasdaq / Health Care Equipment & Services
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2026-07-23
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2026-06-17
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Earnings documents stored for AEMD.

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Investor releaseQuarter not tagged2026-06-17

Aethlon Medical Inc (AEMD) Q4 2026 Earnings Call Highlights: Strategic Advances Amid Financial ...

GuruFocus.com

This article first appeared on GuruFocus. Cash and Cash Equivalents: Approximately $5 million as of March 31, 2026. Net Proceeds Raised: Approximately $1.85 million through the at-the-market program subsequent to fiscal year-end. Operating Expenses: Declined 21.9% year-over-year to approximately $7.3 million. Operating Loss: Decreased to approximately $7.3 million for fiscal 2026 from $9.3 million in the prior fiscal year. Other Income: Approximately $142,000 for the fiscal year ended March 31, 2026, primarily from interest income. Net Loss: $7.2 million for the fiscal year ended March 31, 2026, compared to $13.4 million for the fiscal year ended March 31, 2025. Warning! GuruFocus has detected 6 Warning Signs with QYOUF. Is AEMD fairly valued? Test your thesis with our free DCF calculator. Release Date: June 10, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Aethlon Medical Inc (NASDAQ:AEMD) achieved important clinical research and intellectual property milestones during the fiscal year. The company successfully completed enrollment and treatment of participants in Cohort 2 of its Australian oncology trial with no safety concerns. Aethlon Medical Inc (NASDAQ:AEMD) is expanding the Hemopurifier's applications into additional disease areas through preclinical research. The company has maintained disciplined cost control, resulting in a 21.9% reduction in operating expenses year-over-year. Aethlon Medical Inc (NASDAQ:AEMD) strengthened its balance sheet by raising approximately $1.85 million in net proceeds through its at-the-market program. The company's cash and cash equivalents as of March 31, 2026, were approximately $5 million, which may limit long-term financial flexibility. Despite progress, the Hemopurifier platform is still in the early stages of clinical trials, with primary endpoints focused on safety rather than efficacy. The compassionate use protocol for Ebola is specific and limited to 20 patients at up to 10 centers, which may restrict broader application. Aethlon Medical Inc (NASDAQ:AEMD) experienced screen failures in its oncology trial due to patients not meeting inclusion or exclusion criteria. The company's net loss attributable to common stockholders was $7.2 million for the fiscal year ended March 31, 2026, indicating ongoing financial challenges. Q: Can you clarify the compassion...

Investor releaseQuarter not tagged2026-06-10

Aethlon Medical Announces Fiscal Year End March 31, 2026 Financial Results and Corporate Update

PR Newswire

Australian oncology study advances into Cohort 3 as enrollment continues Entered the third and final dosing cohort of the Australian oncology study, expanded the Hemopurifier intellectual property portfolio, and maintained a focus on managing operating expenses. Conference Call Today at 4:30 p.m. ET SAN DIEGO, June 10, 2026 /PRNewswire/ -- Aethlon Medical, Inc. (the Company or Aethlon) (Nasdaq: AEMD), a clinical-stage medical therapeutic company focused on developing products to treat cancer and life-threatening viral infections for which there is no treatment, today reported financial results for its fiscal year ended March 31, 2026, and provided an update on recent developments. Key Highlights Advanced the Australian oncology study through completion of the first two cohorts and entered the third and final dosing cohort, representing a key clinical milestone toward generating data to inform future development and dosing strategy. Recently treated the first participant in Cohort 3 at Royal North Shore Hospital in Australia. The participant completed three Hemopurifier treatments over a one-week period, marking continued enrollment momentum and execution of the study's final treatment arm. Advanced preclinical research evaluating Hemopurifier applications in additional disease areas, including rheumatoid arthritis and chronic kidney disease, supporting the expansion of the platform's potential addressable market beyond oncology and infectious disease. Continued to strengthen the intellectual property portfolio supporting the Hemopurifier platform, including the issuance of patents in the United States and Europe covering potential applications for long COVID and other coronavirus-related conditions, extending patent protection into the 2040s and enhancing long-term platform value. "Fiscal 2026 was a year of meaningful execution for Aethlon as we advanced our Australian oncology study through the first two cohorts and recently initiated Cohort 3. Advancement into the final cohort represents an important clinical milestone as we work toward generating data that may help define the optimal treatment regimen and guide future development decisions. We also strengthened the Hemopurifier platform through expansion of our intellectual property portfolio and advancement of preclinical research supporting potential applications beyond oncology. Combined with our conti...

Investor releaseQuarter not tagged2026-06-10

Aethlon (AEMD) Q4 2026 Earnings Transcript

Motley Fool

Image source: The Motley Fool. June 10, 2026, 4:30 p.m. ET Chief Executive Officer and Chief Financial Officer — James Frakes Chief Medical Officer — Steven LaRosa Need a quote from a Motley Fool analyst? Email [email protected] James Frakes: Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's Fiscal Year-End March 31, 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 p.m. Eastern Time today, Aethlon Medical released financial results for its fiscal year ended March 31, 2026. 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. 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 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. Now I would like to begin by highlighting progress during the fiscal year ended March 31 going on through the first part of June a...

TranscriptFY2026 Q42026-06-10

FY2026 Q4 earnings call transcript

Earnings source - 63 paragraphs
Operator

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 B. Frakes

Thank you, operator. Good afternoon, everyone. Welcome to Aethlon Medical's fiscal year-end, March 31, 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 P.M. Eastern Time today, Aethlon Medical released financial results for its fiscal year ended March 31, 2026. 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. I will then make some brief remarks on Aethlon's financials. We will open up the call for the Q&A session.

James B. Frakes

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. The Securities Exchange Act of 1934, as amended. The company cautions you that any state 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. Actual results may differ materially from the results anticipated in the forward-looking statements.

James B. Frakes

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 would like to begin by highlighting progress during the fiscal year ended March 31, going on through the first part of June, 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.

James B. Frakes

We continued to advance our oncology program while also expanding our evaluation of Hemopurifier applications into additional disease areas through preclinical research. These efforts reflect our broader objective of establishing the Hemopurifier as a platform technology with potential applications across multiple serious and life-threatening conditions. Taken together, these achievements demonstrate continued execution against our key priorities of clinical development, platform expansion, intellectual property growth, and disciplined resource management. 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. Steve?

Steven LaRosa

Thank you, Jim. Enrollment and treatment of participants in cohort 2 of our Australian oncology trial have been completed. As a reminder, three participants in cohort 2 received two four-hour Hemopurifier treatments during a one-week treatment period. An independent data safety monitoring board reviewed the data, identified no safety concerns, and recommended advancing to the third and final cohort of the study with no protocol modifications. Screening is actively underway at all three investigative sites for this final cohort, where three to six participants will be treated with three Hemopurifier sessions during a one-week period. The first participant in cohort 3 of the study has been enrolled and received three Hemopurifier treatments without any device deficiencies or immediate complications and is now in the safety follow-up period.

Steven LaRosa

Serial extracellular vesicle and T cell measurements on participants in cohort 2 have been measured by the central lab at the University of Sydney. Formal statistical analyses comparing the effects of the three different Hemopurifier dosing regimens on these parameters will be performed by our CRO at the completion of the trial. As a reminder, this is a nine to 18-patient study designed to evaluate the safety and the feasibility of the Hemopurifier treatments and determine an appropriate dosing interval in participants with solid tumors whose disease is stable or progressing while on a treatment that includes anti-PD-1 agents, KEYTRUDA or Opdivo. Segueing now to our preclinical activities.

Steven LaRosa

We are advancing our preclinical extracellular vesicle research activities, including studies evaluating removal of EVs and plasma samples from patients with rheumatoid arthritis and chronic kidney disease. Platelet-derived extracellular vesicles and their cargo have been noted to play a pathogenic role in rheumatoid arthritis. EVs in patients with chronic kidney disease have been demonstrated to contribute to congestive heart failure in this population. These efforts support the concept of a pipeline within a single device, with EV removal as the primary mechanism of action. Separately, I continued our evaluation of the Hemopurifier's compatibility with a simplified blood pump system developed by Stavro Medical. Initial testing assessed flow rates and transfer of dyed fluid to the Hemopurifier. These assessments have been completed and were successful.

Steven LaRosa

Future studies being considered right now include the use of blood or plasma and removal of surrogate markers for extracellular vesicles by the Hemopurifier using this blood pump system. We believe that freeing the Hemopurifier up from a dialysis machine, dialysis unit, and a large double-lumen dialysis catheter would improve the number of physicians able to perform the Hemopurifier treatment and increase the number of places where such a treatment could be performed. For the patient, this could translate into having a less invasive vascular catheter placed and being able to receive their treatment in their therapeutic home. Aethlon Medical is closely monitoring the evolving outbreak of the Bundibugyo species of Ebola in the Democratic Republic of the Congo and Uganda.

Steven LaRosa

The company has previously published in vitro removal data on the Marburg and Zaire species of Ebola from both cell culture fluid and plasma by a miniature version of the Hemopurifier. During the 2014 Zaire outbreak, a single six and a half-hour Hemopurifier treatment of a critically ill Ebola patient with multi-organ failure was associated with a two-log reduction in viral load and clinical recovery. In December 2014, the FDA approved a compassionate use protocol as a supplement to our open IDE for life-threatening viral infections for which there is no treatment. This compassionate use protocol allows for the treatment of up to 20 subjects at up to 10 institutions in the U.S. Recent interactions with the FDA have confirmed that this protocol remains open for enrollment.

Steven LaRosa

Aethlon has shared the above information with both the World Health Organization's R&D Blueprint expert panel, as well as the National Emerging Special Pathogens Training and Education Center, known as NETEC, who works closely with the 13 U.S. regional special pathogen treatment centers that would treat a patient with Ebola in the U.S. should it happen. With that, I'll turn the call back over to Jim for the financial discussion and questions.

James B. Frakes

Thanks, Steve, and good afternoon again, everyone. Turning briefly to the financials, as of March 31st, 2026, we had approximately $5 million in cash and cash equivalents, which provides resources to support ongoing clinical and research activities. Subsequent to fiscal year-end, we further strengthened our balance sheet by raising approximately $1.85 million in net proceeds through our at-the-market program. Turning to some high-level expense analysis, our consolidated operating expenses declined 21.9% year-over-year to approximately $7.3 million, reflecting continued expense discipline and operational efficiency while advancing our clinical and research priorities. That compares to a $9.3 million of operating expenses in the fiscal year ended March 31, 2025. The decrease was primarily due to a $1.1 million reduction in payroll and related expenses, a $500,000 reduction in general and administrative expenses, and a $400,000 reduction in professional fees.

James B. Frakes

Consistent with the reduction in operating expenses, the operating loss for the fiscal year decreased to approximately $7.3 million for fiscal 2026 from $9.3 million in the prior fiscal year. You can find more detail on these expense changes in our 10-K, which breaks down specific drivers by category. Our other income was approximately $142,000 for the fiscal year ended March 31, 2026, primarily reflecting interest income earned on cash balances. That compares to other expense of approximately $4 million in the prior fiscal year. The prior year amount included approximately $4.7 million of non-cash financing-related charges. Overall, our net loss attributable to our common stockholders was $7.2 million for the fiscal year ended March 31, 2026, compared to a net loss of $13.4 million for the fiscal year ended March 31, 2025. We included these earnings results and related commentary in our press release issued this afternoon.

James B. Frakes

The release also included the balance sheet for March 31, 2026 and 2025. The consolidated statements of operations for the fiscal years ended March 31, 2026, and 2025. We will file our annual report on Form 10-K following this call. Our next earnings call for the fiscal first quarter ending June 30, 2026, will coincide with the filing of our quarterly report on Form 10-Q in August 2026. Now, we would be happy to answer any questions that you may have. Operator, please open the call for questions.

Operator

Thank you. To ask a question, you may press star then one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. The first question comes from Marla Marin with Zacks. Please go ahead.

M. Marin

Thank you. A lot going on. Just a couple of housekeeping questions. I want to get back to something that I think you said, Jim, the compassionate use protocol, which is still open. Can you refresh us in terms of It would seem to me, based on my recollection of, I know you treated some seriously ill COVID patients, but it would seem to me that you're well below that threshold that you cited of the number of potential patients to be treated, and the number of medical centers.

James B. Frakes

I believe the Ebola protocol is relevant only to Ebola, so it would be up to 20 Ebola patients at 10 centers.

M. Marin

Got it. Okay.

James B. Frakes

Steve, do you want to

Steven LaRosa

No, that compassion use protocol is specific to Ebola.

James B. Frakes

Right.

Steven LaRosa

It's 20 patients at up to 10 centers.

M. Marin

Okay, got it. It's completely separate from the patients that you had treated in the past under emergency.

James B. Frakes

Yes.

M. Marin

Yes. Okay, got it.

James B. Frakes

That is correct.

M. Marin

Okay, good. Can you give us a little more color on how you're planning to approach the preclinical activities around rheumatoid arthritis? I'm guessing that this is something that will be done in a very cost-efficient manner, because that's what you've been doing in terms of expanding or extending your research activities outside the current ongoing trial. Can you give us some color and also some sense of what the timeline there is?

James B. Frakes

You want to take that or should I?

Steven LaRosa

Sure. Marla, rheumatoid arthritis is just one of the many diseases where platelet-derived EVs, a sizable percentage of the EV population in our blood, is implicated in the disease. What we did is a first instance is test healthy plasma to look for platelet removal of EVs, platelet-derived EVs, and we did that in a single large volume healthy plasma sample. We subsequently purchased, in a cost-effective way, a couple additional healthy plasma samples, and now we are purchasing large volume rheumatoid arthritis samples, and those are all being run at our lab with the focus on the platelet-derived EVs and the microRNA. That work is currently underway. With the chronic kidney, We also, I mentioned chronic kidney disease.

Steven LaRosa

There's been recent publications that these patients have EVs that cause congestive heart failure, which is a huge source of morbidity and mortality in this population. We have purchased small samples of chronic kidney disease plasma, and we're testing them for binding to the resin in our device. Again, that work's being done in-house as well.

M. Marin

How should we think about next steps there? In the past, I know you've contributed to working on peer-reviewed papers. You've presented at different medical presentations. How should we think about next steps depending upon the outcome of the testing that you're doing now?

Steven LaRosa

Yeah, sure. We published a preprint in one of the preprint servers on removal of platelet-derived EVs from a single healthy plasma specimen. The feedback we received is we needed to run more samples and that we needed to also go into a relevant disease sample. With that in mind, we got the additional healthy plasma samples, and we got the rheumatoid arthritis samples, and we think that this will be the data needed to satisfy the reviewers and have an addition to a preprint, an actually peer-reviewed publication on the subject with respect to our device. Same thing with the CKD, chronic kidney disease samples. We'll look at binding to our resin, we would then plan on turning that into an abstract at a medical meeting and a peer-reviewed publication.

Steven LaRosa

Again, trying to fill the preclinical pipeline.

M. Marin

Right. Got it. Building your database in the most cost-effective way that you can. Is that the right way to think about it?

Steven LaRosa

Yeah. I think that's a good way to say it.

M. Marin

Okay. Then last question from me. You've treated the first participant in cohort 3, and I think at your last conference call, you said you were very pleased with the interest that you had seen in participating in the trial. Is that still something that's operating in terms of moving on to treating the next participants?

Steven LaRosa

Yeah, no, we've seen good engagement and commitment from our three sites in terms of screening activity, that remains a positive, bodes well. We did have a few patients that became screen failures for not meeting an inclusion or exclusion criteria. That happens in every study. Unavoidable. The most important thing for me is that the engagement is there and the activity is there.

M. Marin

Okay. Thank you.

James B. Frakes

Thank you, Marla.

Operator

The next question comes from Anthony Vendetti with Maxim Group. Please go ahead.

Anthony Vendetti

Yes, thanks. Just in terms of the efficacy, any endpoints you're looking for or readouts on an efficacy standpoint? Because I know, obviously, the first studies are safety. What are you looking for in terms of efficacy, and are you able to report on those, other than internally know about it, are you able to publish that data?

Steven LaRosa

Yeah. Remember, the primary endpoint for this study is safety.

Anthony Vendetti

Right.

Steven LaRosa

Secondary endpoint is surrogate markers, looking at the Hemopurifier's activity, and those would be EV removal, extracellular vesicle removal, and effects on T cells, including anti-tumor T cells. We previously reported on some qualitative observations from the first cohort, and those are in a prior press release where we saw some changes in EVs and in T cells in the right direction. As I just said, we've just received measurements from cohort 2. The big thing that will occur is at the end of the study, there'll be a formal statistical analysis looking at those dosing regimens between the three different dosing regimens. That will look at magnitude of EV decreases and duration of EV decreases as comparing the three strategies, and again, magnitude and duration of positive effects on T cells. Those will be the major readouts.

Steven LaRosa

The study is not randomized and is small, such that clinical outcomes are not a primary outcome or secondary outcome of the study. It's just way too small for clinical efficacy.

Anthony Vendetti

Right. No, of course, at this stage, yes. Certainly for statistical significance in terms of clinical efficacy, but nonetheless, if they're doing well and you're able to show that, even though that's not the primary endpoint, that's always encouraging. What about any signals suggesting that the Hemopurifier may enhance the therapies like KEYTRUDA or Opdivo?

Steven LaRosa

I would just call your attention to that prior press release that shows that the EVs, including tumor-derived EVs, went down in the first cohort.

Anthony Vendetti

Yeah

Steven LaRosa

that there were improvements in T cells and anti-tumor T cells in the first cohort.

Anthony Vendetti

Okay, any biomarkers or exosome-related findings that have emerged as well? I guess the EVs is what you're talking about.

Steven LaRosa

In the first cohort, of particular interest to us was that EVs carrying PD-L1 on their surface went down during the treatments. These particular population of EVs have been implicated as a cause of resistance to anti-PD-1 therapy. The fact that they went down with treatment, again, at least in the first cohort, was a positive signal that will have to be corroborated, confirmed in the subsequent cohorts and the magnitude and duration will have to be examined. That was of particular interest to me, at least.

Anthony Vendetti

Okay. So far, to sum it up, if I could do so, everything is moving in the direction you would want it to be moving in terms of what you're seeing so far with the patients that have been treated?

Steven LaRosa

Correct.

Anthony Vendetti

Okay, good. Okay. Thank you very much. I'll hop back in the queue. Appreciate it.

James B. Frakes

Thank you, Anthony.

Operator

The next question comes from Jeremy Pearlman with Maxim Group. Please go ahead.

Jeremy Pearlman

Hello?

Steven LaRosa

Hi, Jeremy.

Jeremy Pearlman

Yeah. I didn't dial in. I think the operator by accident did that. I'm sorry. Anthony already asked the question. Thank you.

Steven LaRosa

Got it. Okay.

Operator

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

James B. Frakes

Thank you. In closing, we remain focused on advancing the Hemopurifier platform through disciplined clinical execution and careful capital management. We appreciate your continued interest and support and look forward to speaking with you in August. Thank you very much. Goodbye.

Operator

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

Investor releaseQuarter not tagged2026-06-02

Aethlon Medical to Release Fiscal Year End Financial Results and Host Conference Call on June 10, 2026

PR Newswire

SAN DIEGO, June 2, 2026 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life threatening infectious diseases, today announced that it will issue financial results for its fiscal year end March 31, 2026, at 4:15 p.m. ET on Wednesday, June 10, 2026. Management will host a conference call on Wednesday, June 10, 2026, at 4:30 p.m. ET to review financial results and recent corporate developments. Following management's formal remarks, there will be a question and answer session. Interested parties can register for the conference call by navigating to https://dpregister.com/sreg/10209612/1042263e8ec. Please note that registered participants will receive their dial-in number upon registration. Interested parties without internet access or unable to pre-register may dial in by calling: PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442 All callers should ask for the Aethlon Medical, Inc. conference call. A replay of the call will be available approximately one hour after the end of the call through July 10, 2026. The replay can be accessed via Aethlon Medical's website or by dialing 1-855-669-9658 (USA or Canada) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 7883435. About Aethlon and the Hemopurifier®Aethlon Medical is a medical therapeutic company focused on developing the Hemopurifier, a clinical stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and in pre-clinical studies, the Hemopurifier has demonstrated the removal of harmful exosomes from biological fluids, utilizing its proprietary lectin-based technology. This action has potential applications in cancer, where exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. The Hemopurifier is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the developm...

Investor releaseQuarter not tagged2026-02-16

Aethlon Medical Inc (AEMD) Q3 2026 Earnings Call Highlights: Progress in Oncology Trials and ...

GuruFocus.com

This article first appeared on GuruFocus. Release Date: February 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Aethlon Medical Inc (NASDAQ:AEMD) reported progress in their Australian oncology trial, with successful completion of the first cohort and ongoing treatments in the second cohort. The company is expanding its extracellular vesicle (EV) research platform, supporting the hemopurifier as a potential multi-indication therapeutic. Aethlon Medical Inc (NASDAQ:AEMD) is advancing work on hemopurifier compatibility with a simplified blood treatment system, which could expand clinical and commercial flexibility. The company has achieved sustained operating expense reductions on a year-to-date basis compared to the prior year. Aethlon Medical Inc (NASDAQ:AEMD) has a cash balance of approximately $7 million as of December 31, 2025, indicating a stable financial position. Consolidated operating expenses for the quarter increased by 13.6% compared to the same period last year, primarily due to higher payroll and related costs. The operating loss for the quarter increased to $2.06 million compared to $1.81 million in the prior year period. Interest income earned on cash balances was lower than the previous year, at $44,000 compared to $60,000. The company is still in the early stages of its oncology trial, with the third cohort yet to be initiated, indicating that significant progress is still needed. There are potential regulatory hurdles and compatibility tests required for the integration of the hemopurifier with the new SLAMB SAA system, which could delay future developments. Warning! GuruFocus has detected 2 Warning Sign with AEMD. Is AEMD fairly valued? Test your thesis with our free DCF calculator. Q: You've moved on in the trial to cohort 2. Can you confirm that participants are involved in the trial for the same length of time as cohort 1? A: Yes, the follow-up period is the same. The difference is that in cohort 2, participants receive two hemo purifier treatments instead of one, typically on a Monday and Friday. This allows us to observe the kinetics of EV numbers between treatments and assess if two treatments lead to more lasting effects on EVs and T cells. - Dr. Steven LaRosa, Chief Medical Officer Q: Can you explain the potential impact of connecting the hemo purifier to the SLAM system...

Investor releaseQuarter not tagged2026-02-13

Aethlon Medical Announces Fiscal Q3 2026 Financial Results and Corporate Update

PR Newswire

Clinical and research programs continue to advance, supported by year-to-date cost efficiencies Conference Call Today at 4:30 p.m. ET SAN DIEGO, Feb. 12, 2026 /PRNewswire/ -- Aethlon Medical, Inc. (the Company or Aethlon) (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today reported financial results for its fiscal third quarter ended December 31, 2025, and provided an update on recent developments. Key Highlights Maintained Nasdaq Listing: Continued compliance with Nasdaq listing requirements, with all prior compliance matters remaining resolved. Clinical Progress: Cohort 2 of the Australian oncology trial is actively progressing, reflecting continued clinical execution. Scientific Advancement: Continued advancement of the Company's preclinical extracellular vesicle (EV) research platform, including Long COVID data published on bioRxiv and submitted for peer review, supporting the Hemopurifier's potential as a multi-indication therapeutic approach and a "pipeline within a single device". Technology Development: Continued evaluation of Hemopurifierᆴ (HP) compatibility with a simplified blood treatment system to support broader potential clinical application over time. Operational Efficiency: Maintained disciplined cost controls, resulting in lower year-to-date operating expenses compared to prior year. Clinical and Corporate Update Clinical Progress in Cancer Trial Enrollment and treatment of participants in Cohort 2 of the Australian oncology trial is actively underway, building on Cohort 1, which demonstrated favorable directional improvements in extracellular vesicle and immune cell numbers, as well as safety and tolerability. This nine-to-18 patient study is designed to evaluate the safety and feasibility of the Hemopurifier treatments and determine the appropriate dosing in participants with solid tumors whose disease is stable or progressing while on a treatment that includes the anti-PD-1 agents, Keytrudaᆴ or Opdivoᆴ. Technology Development: Under a Material Transfer Agreement (MTA), Stavro is evaluating the compatibility of the Hemopurifier with their SLAMB system, a simplified blood treatment platform. We believe this research may support future Hemopurifier use in oncology units and infusion centers without requiring a large dialysis catheter, dialysis machines,...

Investor releaseQuarter not tagged2026-02-13

Aethlon Medical, Inc. Q3 2026 Earnings Call Summary

Moby

Progress in the Australian oncology trial is driven by a new patient recruitment strategy utilizing online advertising and phone pre-screening to build a participant pool. The Hemopurifier is being positioned as a 'pipeline within a single device' by exploring its ability to remove extracellular vesicles (EVs) across oncology, Long COVID, and autoimmune indications. Management is evaluating compatibility with the SLAMB system to transition the Hemopurifier from invasive dialysis-based administration to simpler, less-invasive infusion center settings. Operational performance is characterized by significant year-to-date cost reductions of 27% achieved through disciplined payroll and professional fee management. The scientific rationale for the current oncology study was validated through peer-reviewed publication in BMJ Open, supporting the mechanism of EV removal to improve natural immune response. Management targets late March 2026 for a Data Safety Monitoring Board (DSMB) meeting to review safety data from the second cohort of the oncology trial. The transition to the third and final cohort, involving three treatments per week, is contingent on DSMB recommendation and is tentatively planned for April 2026. Future R&D will focus on examining platelet-derived EV and microRNA removal in disease-specific plasma to broaden the therapeutic application of the Hemopurifier. The company assumes that demonstrating compatibility with simplified pump systems will eventually remove the requirement for supervising nephrologists and specialized dialysis units. Cash balance of approximately $7 million as of December 31, 2025, supports ongoing clinical and research activities. Quarterly operating loss increased to $2.06 million due to higher payroll costs, though this was partially offset by lower clinical trial expenses. The company is intentionally limiting the use of outside labs for Long COVID and EV research to maintain strict cost control while advancing preclinical data. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management explained that increasing to two treatments per week allows them to observe the kinetics of EV numbers between sessions. The goal is to determine if more frequent treatments lead to more long-lasting effects on T cells compared to the sing...

TranscriptFY2026 Q32026-02-12

FY2026 Q3 earnings call transcript

Earnings source - 43 paragraphs
Operator

Good day, and welcome to the Aethlon Medical Third Quarter Fiscal 2026 Earnings and Corporate Update Conference Call. [Operator Instructions] Please note that this event is being recorded. I would now like to turn the conference over to CEO and CFO, Jim Frakes. Please go ahead.

James Frakes

Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's Fiscal Third 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 p.m. Eastern Time today, Aethlon Medical released financial results for its fiscal third quarter ended December 31, 2025. 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. 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 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, 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. Now I would like to begin by highlighting progress during the December quarter and early calendar 2026 as we continue to execute against our strategy of advancing the Hemopurifier platform while maintaining disciplined cost control. Key developments include continued enrollment and treatment progress in our Australian oncology trial; ongoing expansion of our extracellular vesicle, or EV, research platform, supporting the Hemopurifier as a potential multi-indication therapeutic; advancement of work evaluating Hemopurifier compatibility with a simplified blood treatment system that could expand future clinical and commercial flexibility; and sustained operating expense reductions on a year-to-date basis compared to the prior year. 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. Steve?

Steven Larosa

Thank you, Jim. Ongoing progress has been made in our Australian oncology trial of the Hemopurifier in participants with solid tumors not responding to a treatment regimen that includes immunotherapy with the anti-PD-1 agent, pembrolizumab, known as Keytruda, or nivolumab, known as Opdivo. We have previously reported the successful completion of the first cohort where 3 participants received a single Hemopurifier treatment without any device-related serious adverse events or dose-limiting toxicities. Favorable directional improvement in EV numbers and immune cell numbers were observed in this cohort with the HP treatment. We have now completed 2 HP treatments in 2 participants in the second cohort of the trial. We have also recently enrolled a third patient who has passed screening and is due to receive the 2 Hemopurifier treatments by the end of March -- excuse me, by the end of February. Once the 3 patients have completed treatment in Cohort 2, safety data will be presented to an independent Data Safety Monitoring Board. We are targeting late March for this meeting. The DSMB will provide Aethlon Medical with a recommendation to either advance to the third and final cohort of the trial where patients will get 3 Hemopurifier treatments in a given week or they may require 3 additional patients in the current cohort. Aethlon has noted an uptick in the number of interested potential participants in the study since we contracted the groups Trialfacts and Dedicated. Trialfacts performs online advertising of the trial, while Dedicated performs phone prescreening of interested participants. Participants who pass this initial screening are then referred on to the 3 investigative sites for informed consent and more detailed screening. This process has already resulted in HP treatment treated patients in the study and has provided a pool of potential future participants for Cohort 3 of the study. As a reminder, this 9 to 18-patient safety feasibility and dose-finding trial is in patients with solid tumors with stable or progressive disease while on a treatment regimen that includes either Keytruda or Opdivo. Patients who meet all exclusion -- all inclusion and no exclusion criteria are enrolled in sequential cohorts to receive 1, 2 or 3 Hemopurifier treatments during a treatment week. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of extracellular vesicles and if these changes in EV concentrations improves the body's own natural ability to attack tumor cells. The scientific rationale and full design of this study have recently been published in the peer-reviewed journal, BMJ Open, and the link to this article could be found on the Aethlon Medical website. I'll now change gears and talk about the R&D update. Under a Material Transfer Agreement, Stavro is studying the compatibility of the Hemopurifier with their SLAMB system. This system utilizes a single small lumen vascular catheter and a simplified blood pump, compared to the large double-lumen vascular catheter and more complicated dialysis machines typically used for the treatment. This research could lead to a simplified system for performing Hemopurifier treatments in oncology units and in infusion centers in the future without the requirement to use a large double-lumen dialysis catheter, a bed in a dialysis unit, a dialysis machine or a supervising nephrologist. The Aethlon Medical R&D team continues to attempt to build on our preclinical data in Long COVID. We have previously shown that the GNA affinity resin in the Hemopurifier binds EVs in Long COVID patient samples and decreases microRNAs known to cause immune dysregulation. This data has been published in the preprint server bioRxiv and has been submitted for consideration in a peer-reviewed journal. We are now exploring possibilities of investigating other cargo within the EVs, such as viral particles, with our technology. Extracellular vesicles, including platelet-derived EVs, have been implicated in the pathogenesis of a myriad of indications in addition to cancer, including, but not limited to, lupus, rheumatoid arthritis, systemic sclerosis, multiple sclerosis, cardiovascular diseases, sepsis and ALS. Aethlon previously published data on the removal of platelet-derived EVs from healthy plasma by the Hemopurifier in the preprint server bioRxiv. We plan to further this work by examining platelet-derived EV and microRNA removal by Hemopurifier -- by the Hemopurifier in patients with some of these indications, so disease plasma, to further this work. This approach is in line with our thinking that the Aethlon Hemopurifier may provide a pipeline within a single device. With that, I'll turn the call back over to Jim for the financial discussion.

James Frakes

Thanks, Steve, and good afternoon again, everyone. Turning briefly to the financials. As of December 31, 2025, we had a cash balance of approximately $7 million. Our consolidated operating expenses for the 3 months ended December 31, 2025 were approximately $2.06 million, up $250,000 or 13.6% compared to the same period last year. This increase was primarily due to higher payroll and related costs, partially offset by lower clinical trial expenses and reduced professional fees, mainly from Investor Relations activities. As a result, the operating loss for the quarter increased to $2.06 million, compared to $1.81 million in the prior year period. Other income, primarily interest income earned on cash balances, was $44,000, slightly lower than the $60,000 recorded in the same quarter last year. Looking at the 9-month period, our operating expenses decreased significantly to $5.36 million, down $1.98 million or 27% from $7.34 million last year. This improvement reflects lower payroll, general and administrative costs and professional fees, highlighting the impact of our ongoing cost management initiatives. 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 December 31, 2025 and the statements of operations for the 3 and 9-month periods ended December 31, 2025 and 2024. We will file our quarterly report on Form 10-Q following this call. Our next earnings call for the fiscal fourth quarter ending March 31, 2026 will coincide with the filing of our annual report on Form 10-K in June 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.

Marla Marin

So I just want to touch on some of the things that you mentioned in the prepared remarks. You've moved on in the trial to Cohort 2. And given that part of the trial's goal is to determine dosage or the number of Hemopurifier treatments and impact that they have on the trial participant, so now you will be administering the treatment twice instead of, with Cohort 1, the onetime treatment. But the participants are involved in the trial for the same length of time. Is that correct?

Steven Larosa

It's the same follow-up period. The difference, as you correctly stated, was, instead of getting 1 Hemopurifier treatment in Cohort 1 and Cohort 2, they get 2. So they get it typically on a Monday and Friday. So a number of days in between. And we'll be able to see the kinetics of how -- what the EV numbers do in between treatments. And then we'll also see if the 2 treatments lead to more long-lasting decreases in EVs and more long-lasting effects on T cells compared to what we saw in the first cohort.

Marla Marin

Okay. Thank you for clarifying that. Okay. Did somebody -- okay. Then my next question is, if it turns out that the -- investigating the potential to connect the Hemopurifier to, I think you called it the SLAMB system, can you give us some indication of like what that would mean in terms of potentially opening new doors or facilitating your ability to get the Hemopurifier into different medical centers potentially down the road?

Steven Larosa

Yes, sure. Yes. So right now, Marla, you have to put in a dialysis catheter, which is a fairly -- we call it kind of in medicine circles, we call it a garden hose. It's a large-bore catheter with 2 lumens, one that you take blood out and then when you return the blood in. That's a pretty invasive device. The SLAMB system uses a much smaller single-lumen catheter that wouldn't have to be put in, in the neck. So in hospitals, there are these things called PICC lines that have pretty much become ubiquitous, that are these small, thin catheters that could be put in the crook of the arm. That's what I would envision. So that would be a big change in terms of the invasiveness of the catheter. Currently, for the Hemopurifier, we use a dialysis machine to run it. We're solely using really the blood pump mechanism of the machine. We're not using all the other bells and whistles that a dialysis machine has because we're not removing any fluids or electrolytes. So we're at the mercy of a dialysis machine securing a bed in a dialysis unit because that's the only place dialysis could be done in the hospital, and having a treating nephrologist because they're the ones who are skilled in using the dialysis machine. So with this SLAMB system, you'd have a single-lumen catheter with a simplified pump, which presumably would be much easier from an operator standpoint. So that opens the ability to do this potentially in an oncology unit where people get their chemotherapy infusions or even in infusion centers, which most hospitals have in their ambulatory centers. So it really opens the door to doing this in oncology units as well as in, say, if it was a patient with autoimmune disease that gets an infusion of whatever immunosuppressive, those kind of units. So it really kind of removes you from the dialysis space. Potentially.

Marla Marin

So just to make sure I understand, it removes you from that dialysis space and makes it much simpler for the hospital staff to administer the treatment. But also from the patient's perspective, it makes it less invasive and probably less daunting to receive the treatment. Is that the right way to think about it?

Steven Larosa

Yes. Because as I say, these PICC lines, they're typically put in what we call the antecubital fossa. That's the space in between your forearm and your upper arm, right, in front of your elbow. Getting a thin catheter there is a lot less daunting to a patient than getting a large catheter placed up in their neck. And they're also easier to take care of as well. They tend to have less complications. So yes, I think that from a patient perspective, I'd much rather have one of these catheters than a dialysis catheter. And I'd much rather be able to stay in my therapeutic home, meaning I'm going to an oncology unit to get my immunotherapy, I'd like to get my EV removal treatment in the same place and not have to go to a dialysis unit to have that done, which is what has to happen now. So it just makes it more integrated into care.

Marla Marin

Got it. Okay. Last question for me. Jim, I know that you are extremely cost conscious about just about everything that the company is doing, and trying to make sure you maximize your R&D spend and your operating costs, optimize the operating costs. So in the press release and in the prepared remarks, you did talk about building upon some of the preclinical research that you had done. Can you just talk a little bit about -- confirm that everything you're doing is consistent with that same very cost-effective approach you're taking generally, and how you're able to do some of what you're doing, like the Long COVID, in a cost-effective manner?

James Frakes

Right. Well, you're right, I can't escape my Scottish heritage, I guess, on the cost containment front. We're trying to keep costs down as much as we can, yet still advance. So we're trying to obtain samples just for shipping costs basically, to the extent we can. We're trying to do the work in-house with our in-house -- with our small scientific staff, trying to limit the work by outside labs. But yet still advance. So we're publishing articles. We are learning things. It's -- we have to make trade-offs, but we do feel like we're advancing it, Marla. While keeping the focus on the oncology trial. We're, again, delighted that we treated 2 out of the likely 3 patients in the second cohort after finishing the first cohort last quarter. So the progress is picking up on that front too.

Marla Marin

No, that is very -- no, that's very apparent that things seem to really be moving forward at the pace that you are finally happy with or that is good to see rather.

James Frakes

Yes. That is true.

Operator

The next question comes from Jeremy Pearlman with Maxim Group.

Jeremy Pearlman

Now first question, related to the oncology trial. You said that the -- more around the time line. Again, this is your best estimate. You said the third patient should be treated by the end of February and then you'll present the safety data by late March. How long do you think the board will respond back whether you can move on to the third cohort or you have to now, let's say, add additional patients into the second cohort? What do you think the time frame for that would be?

Steven Larosa

Great question. So yes, I had misspoke this, so I'm glad you caught my correction. That third patient will be treated at the end of this month, February. And then the Data Safety Monitoring Board will occur likely in late March. Last -- I can only go historically. Last time, following the open session, at the day of the meeting, they had a closed session. And they returned a signed document to me within a couple of hours after. So I would anticipate a decision same day or next business day.

Jeremy Pearlman

Okay. Great. And then let's say, just assuming they move you on to the third and final cohort, how -- and you said also on your prepared remarks that you had a pool of applicants, you saw an uptick of interest of potential participants. How quick do you think you could turn those around to do the 3 Hemopurifier treatments and then -- and get to finalize the last cohort data and then push that through?

Steven Larosa

Yes. So that's a great question. So this is what's really exciting. So thanks to our Controller, Michele Bombardiere. She got this Trialfacts and Dedicated, these groups that Aethlon contracted with. They have been able to supply the site referrals. And so we have a number of these folks lined up. Once we get the -- with the current protocol, you can't enroll or sign a consent for a new patient until you advance to that next cohort. But once we do, those patients can then be approached. They're in the queue, so to speak. They can be approached for consent. There's then a screening period where they get some additional lab test and review. And then we have to line up the HP treatment around their next Hemopurifier treatment. But the really exciting thing is, and again, we can't count our chickens, but there's a queue of potential participants waiting, which is really exciting for me.

James Frakes

And they can roll into the third cohort.

Steven Larosa

They can roll into the third cohort, yes, without any -- yes. They'll sign consent and they'll just move on. And so as opposed to saying, "Now we got to go look," we at least have a pool to draw on.

Jeremy Pearlman

No, that's great. It's really good to have that pool to draw on. And then maybe just -- this is just a theoretical question related to how do you decide on the time gap between the first treatment? Like, you said earlier, a Monday, and then you did the second treatment on a Friday. Is there a specific reason why you chose the 5 days? Or is it -- and is there a possibility where maybe extending the gap between the treatments would be more beneficial to the patient? Is this like the optimal time? I'm just curious.

Steven Larosa

Well, extracellular vesicles are produced by tumors -- people with active tumors continuously. So the turnover is quite rapid. So going in -- again, this is a safety feasibility and our first time in oncology, we said we have to start with a single treatment and see how they do. But we knew it's unlikely that that's going to keep EV numbers down long term, right? So we said, let's try 2 in a week and let's also try 3 in a week, meaning Monday, Wednesday, Friday. We thought anything more than that a patient won't tolerate because, for instance, in dialysis, it's very hard for people to do more than 3 times a week. So we thought that that was the most that somebody would be able to get during a week. And then the other part of the story, which I think you're getting at, is when we look, we'll say, how often do you have to repeat that whatever treatment regimen is? Do you have to do that every week? Do you have to do that every 2 weeks? Do you have to do that once a month? And the way we have our sampling of labs, we'll be able to ascertain that. Is it once a week and then x number of time in between? Is it twice a week with x number of time in, or is it 3 times a week? This was done with a little bit of background information from the plasma exchange trial at Mayo, where they ultimately thought that you needed at least 2 to 3x in a given week to keep EV numbers down. So it was -- the design was informed by what was in the literature in the plasma exchange space.

Jeremy Pearlman

Got it. Understood. And then just last question, related also to this potential incorporating it into the SLAMB system. Is that -- is there going to be any -- would there be any regulatory hurdles from your end? Or since that device is, I'm assuming, is already approved, if it just is compatible, if you could get the Hemopurifier compatible with it, it's ready to go? Or is there some type of you would have to do some sort of a safety test or something related to that before you could use it into that system?

Steven Larosa

Yes. Well, they're submitting their -- they're working on their submission to the FDA. It's not already approved. So they'll have to do that. And then we would have to roll it in. I'm sure we would be expected to do a certain number of treatments with the 2 in place. So it's not -- that's the plan.

Operator

The next question comes from RK with H.C. Wainwright.

Swayampakula Ramakanth

A couple of quick questions. With the Cohort 2, 2 out of 3 patients in, and if I understood it correctly, you are basically using the same patients who had -- who were in Cohort 1 into the Cohort 2? If that is true?

Steven Larosa

No. These are entirely new. These aren't the same patients that were in Cohort 1. These are entirely new patients.

Swayampakula Ramakanth

Okay. So they're entirely new. Okay. Fine. So what -- you said the third patient is starting at the end of this month. So do you think in a couple of months down the line, we should be done with this Cohort 2? And the real question is, is there a real need to do Cohort 3? Or do you think with Cohort 2, you would be able to judge if 2 treatments with Hemopurifier is enough to get the benefit that they could get? Or you still think you would need to do Cohort 3?

Steven Larosa

Okay. So a bunch of questions there. One is, yes, you're right, the third patient is going to get their 2 HP treatments at the end of this month. Following that, the independent Data Safety Monitoring Board will decide if that's sufficient or whether -- because it's a 3 plus 3 safety study, they'll decide whether it's sufficient or whether we need to add 3 additional patients. So I can't know, wouldn't be appropriate for me to speak for them. But in the best possible scenario, by the time they meet at the end of March, we would have a directive to go ahead and begin in April with Cohort 3. To get to your next question about the need for Cohort 3, well, again, this is based on the Mayo Clinic data, which suggested that you needed 2 or 3. I think we would be really hamstringing ourselves to stop at 2 and not investigate 3 because I have every reason to believe 3 could potentially be superior to 2 in terms of EV removal or T cells. So I think we would be selling ourselves short to stop at 2. And I haven't seen any of the data from 2 to actually even prognosticate yet. So it's way premature to call on the efficacy of 2 right now.

James Frakes

It was a good question, but no, it's -- without knowing the data -- right.

Swayampakula Ramakanth

Okay. So then I have a couple of questions on the SLAMB device, so -- integration. As you were stating, when you go from the dialysis machine to this machine, the tubing itself, the catheters itself are smaller in size, which makes the patient feel not so cumbersome. But on the other hand, the flow dynamics of the blood changes quite a bit between the larger tubing and the smaller tubing. So do you see that you might have to go through this rigmarole one more time with that machine because the flow dynamics have changed? The amount of capture of the EVs could be different because of the dynamics? What do you think?

Steven Larosa

Yes. Again, a lot of forward-looking questions there, but yes, so the first thing is -- the simple -- the first set of experiments is simply: is their pump compatible with the device, meaning does our device function without triggering alarms and clotting off, et cetera? They'll be using -- they'll be doing this, not on patients, but they'll be doing it in the lab with colored fluid and look at the pressures, et cetera. Then you're right, there probably would have to be some ex vivo experiments looking to see -- make sure the EV capture is similar, yes. So this is just the first step, is seeing the compatibility of the device -- of their pump with our device.

Swayampakula Ramakanth

Okay. So basically, that's not going to really help us move this trial any faster at this point. So it's something in the future basically, correct?

Steven Larosa

Not the current trial and probably not even the next trial. I don't think it'd be done in time.

Swayampakula Ramakanth

Okay. And then the last question from me is, at one point you were talking about India and then you kind of walked away from that idea. Do you still see a possibility of having the Indian hospital get back into doing a clinical trial so you can kind of speed up the progress here? Or is it first Australia and then we'll see what happens?

James Frakes

Yes. I think we're pretty highly focused on Australia, RK. We'd be -- while the PI is great there and the hospital is great, we're advancing at a very good pace right now in Australia. And we just want to finish executing and get this trial done and get the data out. I think there'll be some expense and some distraction. So the answer is no, we're not going to go back there.

Steven Larosa

It'd be hard to advance to a PMA trial if you had another safety feasibility trial going on somewhere else in the world.

James Frakes

Right. If there's an emergency, if there's a pandemic breaking out in India, we know them, the PI is very comfortable with our device, we certainly could do an emergency use situation there. I wouldn't hesitate to consider that. But in terms of going back and doing a safety trial, no.

Operator

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

James Frakes

In closing, we remain focused on advancing the Hemopurifier platform through disciplined clinical execution and careful capital management. We appreciate your continued interest and support. Have a good day. Goodbye.

Operator

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

Investor releaseQuarter not tagged2026-02-04

Aethlon Medical to Release Fiscal Third Quarter Financial Results and Host Conference Call on February 12, 2026

PR Newswire

SAN DIEGO, Feb. 4, 2026 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life threatening infectious diseases, today announced that it will issue financial results for its fiscal third quarter ended December 31, 2025, at 4:15 p.m. ET on Thursday, February 12, 2026. Management will host a conference call on Thursday, February 12, 2026, at 4:30 p.m. ET to review financial results and recent corporate developments. Following management's formal remarks, there will be a question and answer session. Interested parties can register for the conference call by navigating to https://dpregister.com/sreg/10206585/1034a255186. Please note that registered participants will receive their dial-in number upon registration. Interested parties without internet access or unable to pre-register may dial in by calling: PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741 PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442 All callers should ask for the Aethlon Medical, Inc. conference call. A replay of the call will be available approximately one hour after the end of the call through March 12, 2026. The replay can be accessed via Aethlon Medical's website or by dialing 1-855-669-9658 (USA or Canada) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 3024961. About Aethlon and the Hemopurifierᆴ Aethlon Medical is a medical therapeutic company focused on developing the Hemopurifier, a clinical stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and in pre-clinical studies, the Hemopurifier has demonstrated the removal of harmful exosomes from biological fluids, utilizing its proprietary lectin-based technology. This action has potential applications in cancer, where exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. The Hemopurifier is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to part...

Investor releaseQuarter not tagged2025-11-13

Aethlon Medical Announces Fiscal Q2 2025 Financial Results and Corporate Update

PR Newswire

Clinical and research progress continues alongside substantial cost reductions. Conference Call Today at 4:30 p.m. ET SAN DIEGO, Nov. 12, 2025 /PRNewswire/ -- Aethlon Medical, Inc. (the Company or Aethlon) (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today reported financial results for its fiscal second quarter ended September 30, 2025, and provided an update on recent developments. Key Highlights Maintained Nasdaq Listing: Compliance matters resolved, Aethlon remains in good standing with Nasdaq. Clinical Progress: Recruitment underway for Cohort 2 of the Australian oncology trial under amended protocol. Scientific Advancement: Ongoing collaboration with UCSF on Long COVID research, with a manuscript in preparation for peer-reviewed journal. Technology Development: Initiated evaluation of Hemopurifier compatibility with a simplified blood treatment system Operational Efficiency: Operating expenses reduced by 48%, reflecting disciplined cost management. Clinical and Corporate Update Clinical Progress in Cancer Trial Aethlon continues to advance its clinical, scientific, and operational initiatives in support of its mission to develop therapeutic devices for cancer and infectious diseases. Nasdaq compliance matters have been resolved, and the company remains listed on the Capital Market. Recruitment has begun for the second cohort of the Australian oncology trial of the Hemopurifier® is underway under the amended protocol that allows patients receiving combination therapies with Pembrolizumab (Keytruda®) or Nivolumab (Opdivo®). The study is designed to evaluate safety, feasibility, and dose-finding in patients with solid tumors who have not responded to PD-1 therapy. Additional cohorts will examine whether sequential Hemopurifier treatments decrease extracellular vesicle (EV) concentrations and enhance the body's immune response against tumor cells. As previously reported, the laboratory of Professor Georges Grau at the University of Sydney analyzed EVs and lymphocyte counts in samples from patients in the first cohort before and after Hemopurifier treatment. EVs are nanoparticles that are involved in cell-to-cell communication and are implicated in the spread of cancer (metastasis), growth of new blood vessels to the tumor, (angiogenesis), cell death (apoptosis), and i...

TranscriptFY2026 Q22025-11-12

FY2026 Q2 earnings call transcript

Earnings source - 35 paragraphs
Operator

Good day, and welcome to the Aethlon Medical Second Quarter Fiscal 2026 Earnings and Corporate Update Conference Call. [Operator Instructions] Please note today's event is being recorded. I would now like to turn the conference over to Jim Frakes, CEO and CFO. Please go ahead.

James Frakes

Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's Fiscal Second 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 p.m. Eastern Time today, Aethlon Medical released financial results for its fiscal second quarter ended September 30, 2025. 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. 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 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, 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. 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. Steve?

Steven Larosa

Thank you, Jim. I'll start off with the clinical update. Ongoing progress has been made in our Australian oncology trial of the Hemopurifier in participants with solid tumors not responding to a regimen that includes immunotherapy with an anti-PD-1 agent. We've completed Hemopurifier treatments in the three participants in Cohort 1. All three participants completed a single 4-hour Hemopurifier treatment without any device deficiencies or immediate complications. At the prespecified 7-day safety follow-up, none of the three participants experienced a dose-limiting toxicity, or a device-related serious adverse event, an independent data safety monitoring board that was convened on July 11, 2025, recommended advancing to the second cohort where participants will receive two Hemopurifier treatments during a 1-week treatment period. All three investigative sites in Australia have been busy prescreening potential participants for the second cohort. Potential participants have been identified by these screening efforts and these participants are currently reviewing the informed consent document. In an attempt to accelerate enrollment, Aethlon has embarked on a 3-pronged strategy. First, we held a virtual investigator meeting with the three Australian principal investigators and sites to share best practices for identifying potential participants and describing the trial to those participants; two, we are working with our Australian CRO, ResQ, to identify one to two additional new sites; and three, we've engaged the company Trialfacts to perform clinical trial advertising, online prescreenings and referral of potential participants to the investigative sites. As a reminder, the primary endpoint of the approximate 9 to 18 patients safety, feasibility and dose-finding trial is safety. Safety is determined by monitoring for the incidence of adverse events and clinically significant changes in blood tests following the Hemopurifier treatments. The trial involves patients who are not responding to a treatment regimen that includes an anti-PD-1 agent and the participants will receive either 1, 2 or 3 Hemopurifier treatments during a 1-week treatment period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentrations of extracellular vesicle or EVs. And if changes in these EV concentrations improve the body's own natural ability to attack tumor cells. These exploratory central laboratory analyses will inform the design of later efficacy and safety trials, including a premarket approval study known as a PMA study, required by the FDA and other regulatory agencies. As described in our press release from October 7, 2025, the laboratory of Professor Georges Grau at University of Sydney has performed analysis of extracellular vesicle, EV number and lymphocyte counts on samples before and after the HP treatment in the three patients in the first cohort. EVs are nanoparticles that participate in cell-to-cell communication and are implicated in the spread of cancer known as metastasis, the growth of new blood vessels to the tumor, known as -- called angiogenesis, and also inhibit the body's T cells, which are important for killing tumor cells. Two of the three participants in the trial showed decreases in large EVs, known as microvesicles, following the Hemopurifier treatment. When examining the subsets of EVs, decreases were also noted in large and small platelet-derived EVs, in two of the three patients. We observed decreases in the subset of large EVs carrying the ligand PD-L1 in all three participants during the Hemopurifier treatment. Persistently elevated counts of EVs with PD-L1 have been associated with a lack of response to anti-PD-1 agents. Following a single 4-hour Hemopurifier treatment decreases were also observed in 7 out of 10 microRNAs examined in two of the three participants. MicroRNAs are about one component of the cargo of extracellular vesicles, and have been previously been reported to promote cancer growth and metastasis. After a single 4-hour treatment improvements in laboratory ratios associated with responses to immunotherapy were noted in two of the three participants. These ratios included the neutrophil to lymphocyte ratio, monocyte to lymphocyte, lymphocyte to albumin and the systemic immune-inflammation Index. Increase were noted in total T cells, CD8 and CD4 T cell subsets, and tumor-specific CD137 positive T cells in participants following the Hemopurifier treatment. Heterogeneity was noted in the time to these changes in the three participants and the magnitude of the changes observed. Additional data from the subsequent two cohorts will help to determine whether these observations are reproducible, and whether there is a dose response with additional Hemopurifier treatments in terms of the magnitude and the duration of these changes. I'll now switch to an update on the preclinical R&D activities. Aethlon Medical presented preclinical data on August 12, 2025, at the Keystone Symposium on Long COVID and other post-acute infection syndromes. Long-standing symptoms following acute COVID-19 infection, known as Long COVID, have been demonstrated to effect approximately 400 million individuals worldwide with a global economic burden of $1 trillion per year. No treatment has been approved by a regulatory agency for the treatment of long COVID. Extracellular vesicle have been implicated in the pathogenesis of Long COVID. The data we presented demonstrated that large and small extracellular vesicles from Long COVID patients bound to the GNA lectin and the lectin affinity resin that's present in the Aethlon Hemopurifier. Following this presentation, Aethlon's R&D lab has focused on studying the cargo of the extracellular vesicles removed from the Long COVID patient samples. We are currently preparing a manuscript for submission with these results with plans on submitting to a preprint server and a peer-reviewed journal, in a publication that's being done with our collaborators at UCSF Medical Center. Recently, Aethlon Medical signed a material transfer agreement, an MTA, to study the compatibility of the Aethlon Hemopurifier with a system that utilizes a single small-lumen vascular catheter and a simplified blood pump. Currently, operation of the Hemopurifier requires a large double-lumen dialysis catheter, a more complicated dialysis machine as well as supervising nephrologists, dialysis nurses and the requirement for a dialysis unit bed. The research done under this MTA could lead to a simplified system for performing Hemopurifier treatments in oncology units in the future. With that, I'll turn the call over to Jim for the financial discussion and questions.

James Frakes

Thanks, Steve, and good afternoon again, everyone. Let's touch briefly on the financials. As of September 30, 2025, we had a cash balance of approximately $5.8 million. Our consolidated operating expenses for the 3 months ended September 30, 2025, were approximately $1.5 million, down by approximately $1.4 million or 48%, from $2.9 million in the same period of 2024. The decreases were reflected across our expense categories of payroll, general and administrative expenses and professional fees. Our payroll and related expenses decreased by approximately $778,000, reflecting lower headcount, reduced bonus accruals, and absence of prior year severance charges. Our general and administrative expenses declined by approximately $437,000 driven by lower clinical trial costs and in part due to a $218,000 R&D tax incentive credit from the Australian government as well as reductions in supplies, insurance and other operational costs. And our professional fees decreased by approximately $177,000, mainly from reduced investor relations and contract labor expenses, partially offset by higher legal tax audit and financial services costs. As a result of these factors, our operating loss for the quarter decreased to $1.5 million, again, compared to $2.8 million in the prior year period, reflecting solid progress in aligning our resources with our strategic priorities. You can find more detail on these expense changes in our Form 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 September 30, 2025, and the statements of operations for the 3- and 6-month periods ended September 30, 2025 and 2024. We will file our quarterly report on Form 10-Q following this call. Our next earnings call for the fiscal third quarter ending December 31, 2025, will coincide with the filing of our quarterly report on Form 10-Q in February 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] Today's first question comes from Marla Marin with Zacks.

Marla Marin

So I just want to understand one thing in terms of the recruitment for Cohort 2, to what extent will potential participants understand that you are moving forward and that there were some positive responses in Cohort 1? Or that doesn't come into play at all?

James Frakes

Steve?

Steven Larosa

Marla. Yes, so it's a good question. So when we had our virtual investigator meeting, we went over again with the investigators, what we saw in terms of observations with the EVs and the T cells in the first cohort, so that they would understand those and be able to explain them. And then we also had a very, I think, good discussion about how to describe this trial to the patients. So there was a lot of good input from all three PIs. So I think the investigator meeting had a lot of value from that perspective.

Marla Marin

Okay. And then also so you had -- as you have been explaining for a while, there was a follow-up with the Cohort 1 participants, a 7-day follow-up. Is there any sense in terms of subsequently whether there's -- that group of those three people are still performing in the way that you would expect or that wouldn't be in any way statistically meaningful data to have?

Steven Larosa

Well, we have -- the observations were based on the labs that went out to 8 weeks. So we have all that data for those patients. So there's no subsequent EV or T cell data that we expect from that group of patients. And then although we are following them clinically, that is not an endpoint. This is an early safety and feasibility trial. So we can't make any comments about the clinical response.

Marla Marin

Okay. Right. That makes sense. And with Cohort 2, can you just remind us in terms of you're looking for, this as a dosage finding study as well as safety study. So what should we be thinking about once you down the road when you release top line data, what you'll be looking for?

Steven Larosa

Yes. So great question. So in Cohort 2, during a 1-week period, the patient will get -- the participant will get to HP treatment. So Monday, Friday would be the schedule as opposed to a single treatment. So what we would like to see not only most importantly, can someone tolerate two treatments in a week. That's the main objective. But what we'd like to see is that the EV decreases that we observed in the first cohort would be more profound because they're getting two treatments instead of one. And that the T cell changes would also increase over time. So a dose response, even though it's a device, not a drug, a dose response. And then, of course, reproducing what we saw in the first three patients. So I think the next tranche of data will give us more information than we have right now.

Marla Marin

Yes. Okay. Yes, that makes sense. And your -- as I think you've said in the past, you're not walking away from some of the other indications where you think the Hemopurifier can be effective. But given the realities of budgets and time constraints and all, you're not investing a lot of time or money in some of these other indications. So the paper that you wrote and then the presentation at the medical forum, are those the kind of things that we should think about for you going forward in the near term to try to keep people apprised of what's going on with the Hemopurifier?

Steven Larosa

Yes. No. As we've talked about before, I think EV reductions are relevant in a large number of indications. We've got to focus our efforts because of our staff and amount of funding. I would expect in the near term that we will have a preprint on our Long COVID data. So that's something to look forward to. And that data will also simultaneously get submitted to a peer-reviewed journal, which, of course, gets -- as I said, peer review. So that would be the next. So the Long COVID data. And then we -- as we can, we will look at EVs and other diseases. But again, we have -- as you said, we have to be focused based on our resources.

James Frakes

So we are monitoring other indications, but we're trying to stay focused.

Marla Marin

Right. No, no, I get it. And then, Jim, a question for you in terms of you're always looking for ways to stretch or optimize your spending. I'm guessing that at this point, you really -- there's not a lot that you can do because you've pretty much optimized your spending. In terms of -- in the past, like quite a long time ago, there were some -- you had access to some sort of government funding that was not dilutive. Have you thought about that again? Or is that really not applicable now as you're moving through clinical trials?

James Frakes

Well, if the -- a government contract was aligned close to perfectly with our goals we would be interested. But if it was an excursion into a different field, it's just -- especially with the current administration cutting overhead on these contracts, they weren't all that profitable before. And now with the overhead reductions, I think that it's probably breakeven or close to breakeven at best. So it would have to dovetail really well with our goals -- to help us get to those goals more efficiently. So we're not averse to doing it, but it has to be the right contract or grant.

Operator

And our next question today comes from Jeremy Pearlman of Maxim Group.

Jeremy Pearlman

Okay. So you had approval for -- to move on to the second cohort, roughly 4 months ago. Maybe if you could explain or why -- or hypothesize why you think it's taking so long to recruit patients?

James Frakes

Steve?

Steven Larosa

Yes. It's -- as we've kind of said before, this is not an easy sell to patients. Cancer patients don't usually get a large catheter put in and get their blood filtered over a machine. And so that takes some explaining. So I think -- and there's a lot of time points where patients have to get samples done. So -- and then explaining to a patient what the -- in a safety and feasibility trial, what the value would be to them, we had a lot of discussions at the investigator meeting. So it's an EV removal in cancer is a novel concept. And extracorporeal therapies for cancer patients are -- is a novel concept, and that just requires some explaining to them. And -- so the slow enrollment to me is not all that unexpected.

Jeremy Pearlman

Okay. Understood. And you -- based on that -- based on these new initiatives you're instituting to try and accelerate enrollment, do you still think by a time line for completion of the second cohort by the end of, let's say, mid-2026. Is that reasonable? Or how should we look at the -- based on these time lines?

Steven Larosa

Yes. I mean, we've tried to say that we would anticipate one patient per month. One of the things one must bear in mind is that it is now summer in Australia. So people are going on vacation and it's the holiday. So a slowdown during the holidays, I would not be unexpected. But one patient a month is what we're targeting. We do hope that the -- we're not standing pat. As I've said, -- we've engaged this company called Trialfacts. So they're actually doing digital marketing. They're doing an online screening form and then they're referring potentially eligible patients to the sites. I think that will help. And we're actually looking for an additional one to two sites. So we're trying to exhaust every avenue to try to ramp things up.

Jeremy Pearlman

Okay. That's great. And then just the last question related to some of the data that you talked about earlier on the call and that was in the press release today. Is that -- does that fit in with your hypothesis that this could help extend the patient life or help improve patients who have -- who are going under immunotherapy as well? Or is it not enough of a decrease yet in the T cells and the EVs?

Steven Larosa

Yes. So I'm always cautious because it's three patients. That's probably the most important thing. So the more patients, the more confidence one would have. But directionally, EV decreases is what we want to see, and we're seeing that overall and in some subsets and some improvement in different lymphocyte populations that are involved in tumor killing, they're going directionally in the right way. So if we see that this is reproducible in the next cohort and that the magnitude of the changes is increased, that would give one more confidence. So yes, things -- at least what we're seeing now, we're seeing directionally -- directional changes that we wanted to see.

Operator

And our next question today comes from Sean Lee of H.C. Wainwright.

Xun Lee

This is Sean here for RK. I just have two quick ones. First, on the Australian study. Regarding the lower EV levels that you saw, was that directly following treatment or after a period of time? And were you -- was that stable following levels? Did the EV levels rebound after a while?

Steven Larosa

Yes. So what we did is we got a sample before they went on the machine -- before they went on the device, one at 2 hours into their treatment and one at 4 hours. So at the end of the treatment, and then subsequent weeks 1, 2, 3, 4 and 8 following treatment. And so we saw, again, particularly in the larger EV populations, decreases during the treatment, so at the 2-hour and 4-hour time point. And as -- because EVs are being produced continuously, you do see a rebound usually over the course of a couple of weeks. And so yes, they do start going back up. So what you'd like to now examine because this is a dose-finding study as well is that with more treatments in a given week, the EVs will both go down further and stay down longer. But we've only got the single treatment so far. So yes, they go down during the treatment, and then they do start rising after a couple of weeks after the treatment.

James Frakes

Which was expected.

Steven Larosa

And that's totally expected, yes.

Xun Lee

I think you mentioned that the follow-up for 8 weeks doing Cohort 1. For Cohort 2, are you expecting to follow them any longer? Or are we still looking at the 8 weeks data in maximum?

Steven Larosa

Yes. No, the EV and T cell data only goes out to post-treatment week 8. We don't go any further than that.

Operator

And that concludes our question-and-answer session. I'd like to turn the conference back over to Jim Frakes for any closing remarks.

James Frakes

I'd like to thank you again for joining us today in our discussion of our fiscal second quarter results, and we look forward to keeping you up-to-date on future calls. Thanks again. Goodbye.

Operator

Thank you. That concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines, and have a wonderful day.

As of 2026-06-20 • Updated weeklySource: Earnings sourceIngestion runbook