Aethlon Medical signals expanded Australian oncology enrollment strategy while operating loss narrows to $1.5M

Earnings Call Insights: Aethlon Medical (AEMD) Q2 2026

MANAGEMENT VIEW

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CEO James Frakes opened the call highlighting progress on the Australian oncology trial and ongoing alignment of resources with strategic priorities. "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." (CEO James Frakes)

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Chief Medical Officer Steven Larosa reported, "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." He confirmed completion of Cohort 1 treatments without immediate complications, with the independent data safety monitoring board recommending advancement to Cohort 2.

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Dr. Larosa outlined a three-pronged strategy to accelerate enrollment: holding a virtual investigator meeting to share best practices, working with the Australian CRO ResQ to add new sites, and engaging Trialfacts for clinical trial advertising and online prescreening.

OUTLOOK

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Management expects Cohort 2 enrollment to proceed at a targeted rate of one patient per month, acknowledging anticipated holiday slowdowns in Australia. Dr. Larosa added, "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...I think that will help. And we're actually looking for an additional one to two sites."

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The focus remains on completing the Australian trial, with ongoing evaluation of Hemopurifier's effect on extracellular vesicle (EV) reduction and immune response, to inform future premarket approval studies.

FINANCIAL RESULTS

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CEO James Frakes stated, "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."

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Payroll and related expenses decreased by $778,000 due to lower headcount and reduced bonus accruals. General and administrative expenses declined by $437,000, driven by lower clinical trial costs and a $218,000 R&D tax incentive credit from the Australian government. Professional fees also decreased by $177,000, offset slightly by higher legal and financial services costs.

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Operating loss for the quarter decreased to $1.5 million, compared to $2.8 million in the prior year period.

Q&A

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Marla Marin, Zacks Investment Research: Asked how the investigator meeting informed communications with potential Cohort 2 participants. Dr. Larosa explained, "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."

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Marin questioned ongoing follow-up for Cohort 1. Dr. Larosa responded, "the observations were based on the labs that went out to 8 weeks. So we have all that data for those patients."

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Marin asked about near-term focus and potential publications. Dr. Larosa confirmed, "I would expect in the near term that we will have a preprint on our Long COVID data."

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Marin inquired about optimizing spending and potential for non-dilutive funding. Frakes stated, "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 probably breakeven or close to breakeven at best."

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Jeremy Pearlman, Maxim Group: Asked about recruitment delays and expectations for Cohort 2 completion. Dr. Larosa clarified, "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 the slow enrollment to me is not all that unexpected."

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Pearlman followed up on digital outreach and trial timing. Dr. Larosa replied, "one patient a month is what we're targeting."

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Pearlman questioned if EV and T cell data fits with efficacy hypothesis. Dr. Larosa stated, "directionally, EV decreases is what we want to see, and we're seeing that overall...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."

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Xun Lee, H.C. Wainwright: Asked about the timing and durability of EV reductions. Dr. Larosa described the data collection and noted, "during the treatment, so at the 2-hour and 4-hour time point...you do see a rebound usually over the course of a couple of weeks."

SENTIMENT ANALYSIS

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Analysts maintained a neutral to slightly positive tone, focused on trial progress, recruitment challenges, and the potential for publication of new data. Questions probed practical aspects of trial execution and resource allocation.

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Management delivered responses with a neutral and fact-based tone, avoiding overstatement. Phrases such as "we do hope," "we're not standing pat," and "directionally...is what we want to see" indicated cautious optimism.

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Compared to the previous quarter, the sentiment remained steady, with both analysts and management showing continued interest in trial milestones and financial stewardship, but with a more active focus on accelerating patient recruitment this quarter.

QUARTER-OVER-QUARTER COMPARISON

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The current quarter saw a more detailed discussion of active recruitment strategies, including digital marketing and potential site expansion, compared to last quarter's focus on protocol amendments and trial site screening.

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There was a sharper focus on operational cost reductions this quarter, with explicit details on payroll, administrative, and professional fees.

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Analyst attention shifted from strategic decisions about trial locations (e.g., India) in the previous quarter to immediate practical concerns about recruitment rates and interim data publication in the current quarter.

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Management's tone remained measured, with continued emphasis on safety endpoints and resource alignment, while expressing a more proactive approach to enrollment challenges.

RISKS AND CONCERNS

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Management highlighted slow patient enrollment in the Australian trial and the challenges of explaining extracorporeal therapies to cancer patients.

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Seasonal factors, such as the Australian holiday period, were acknowledged as likely to further slow enrollment.

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Financial sustainability remains dependent on careful cost control and, potentially, the alignment of future government funding opportunities with core business goals, as Frakes noted.

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Analyst questions reflected concern over recruitment pace, trial data durability, and the narrow focus required by limited resources.

FINAL TAKEAWAY

Aethlon Medical emphasized progress in its Australian oncology trial, with Cohort 1 completed and a multi-pronged strategy underway to accelerate Cohort 2 enrollment. Financial discipline has resulted in a significantly lower operating loss and strengthened cash position. Management remains focused on executing within its resource constraints and leveraging new data to inform future studies, while analysts continue to monitor recruitment timelines, operational efficiency, and the company’s ability to generate actionable clinical insights from its Hemopurifier platform.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/aemd/earnings/transcripts]

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