Aethlon Medical, Inc. (AEMD): Business Model Canvas [Dec-2025 Updated]

You're looking at Aethlon Medical, Inc. (AEMD), a classic high-risk, high-reward biotech where the entire valuation is tied to one piece of hardware: the Hemopurifier. This is a clinical-stage model, so the near-term financial picture is stark: in the 2025 fiscal year, the company reported a net loss of around $12.5 million against minimal grant revenue of approximately $200,000. But what you're really buying is the potential of a platform technology that can treat everything from cancer by removing immuno-suppressive exosomes to severe viral infections. The key is execution-getting the device through FDA trials and into the hands of specialized hospitals. This is a capital-intensive race against the clock, and the Business Model Canvas below maps out exactly where the risks and massive opportunities lie.

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Key Partnerships

For a clinical-stage biotech, these relationships are defintely about validation and distribution, not just cost savings. Aethlon Medical, Inc. needs experts to run the trials and potential partners to scale the Hemopurifier. This is a high-stakes, high-collaboration model.

The company's partnership strategy is laser-focused on generating the clinical data that proves the Hemopurifier works, which means collaborating with top-tier academic and clinical sites. You can't get FDA Premarket Approval (PMA) without that rigor, so these sites are the true gatekeepers.

Clinical Trial Sites for Data Generation

The core partnership lies with the clinical centers running the pivotal oncology trial. As of late 2025, the Australian oncology trial is the primary focus, with three clinical sites actively screening patients for Cohort 2 under an amended protocol. This is where the rubber meets the road for the Hemopurifier.

The initial patient was treated at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital. A third site, Genesis Care/Royal North Shore Hospital, was activated in February 2025. These centers provide the specialized infrastructure-like dialysis and Continuous Renal Replacement Therapy (CRRT) machines-that makes the Hemopurifier a plug-and-play tool.

Academic and Research Collaborations

Beyond oncology, Aethlon is strategically partnering with academic centers to explore new indications, which is smart risk diversification. The most notable collaboration as of late 2025 is with the University of California San Francisco Medical Center (UCSF) Long COVID clinic. This partnership is focused on pre-clinical research, specifically obtaining samples from Long COVID patients to test the Hemopurifier's ability to remove extracellular vesicles (EVs), which are implicated in the disease pathogenesis. Initial observations from this analysis were expected in September 2025.

Government and Financial Support Agencies

While Aethlon Medical, Inc. is not currently reporting a major new grant from the National Institutes of Health (NIH) or Biomedical Advanced Research and Development Authority (BARDA) in 2025, they are leveraging government support tied to their international clinical work. Specifically, the company received a $218,000 R&D tax incentive in the fiscal second quarter ended September 30, 2025. This Australian R&D tax incentive helps offset the cost of the oncology trial, effectively acting as non-dilutive funding that reduces their general and administrative expenses.

Here's the quick math on that efficiency:

Functional Biopharma Partnerships

Aethlon Medical, Inc. doesn't have a formal co-development deal with a major pharmaceutical company yet, but their clinical strategy creates a crucial functional partnership with existing blockbuster drugs. The Australian trial protocol assesses the Hemopurifier in combination with anti-PD-1 agents like Pembrolizumab (Keytruda) and Nivolumab (Opdivo).

This is a smart move because it positions the Hemopurifier as a potential add-on therapy to existing, approved standards of care, rather than a standalone drug. The goal is to show that removing tumor-derived extracellular vesicles (EVs) improves the efficacy of these checkpoint inhibitors.

• Clinical Validation: Three Australian medical centers are running the trial.
• Academic Expertise: Collaboration with UCSF on Long COVID research.
• Financial Support: Benefit from a $218,000 Australian R&D tax incentive in Q2 2025.
• Strategic Alignment: Trials combine Hemopurifier with existing anti-PD-1 agents.

What this estimate hides is the risk that a formal co-development partner won't materialize until the Phase I data is truly compelling.

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Key Activities

The core work here is not selling, but proving the technology works and getting it approved. Every dollar spent must drive the Hemopurifier closer to market clearance. This is a capital-intensive race against the clock, which is why the company's operating loss for the fiscal year ended March 31, 2025, was still approximately $9.3 million, even after significant cost reductions. You are essentially funding a series of high-stakes experiments.

The company's focus is razor-sharp: advance the Hemopurifier through clinical and preclinical stages, protect the underlying technology, and manage the regulatory gauntlet. This focus is clear in the Q2 2026 (ended September 30, 2025) financials, where consolidated operating expenses dropped by 48% year-over-year to approximately $1.5 million, showing disciplined cost management while still advancing trials. That's operational discipline.

Advance FDA Clinical Trials (e.g., IDE studies)

The most critical activity is the clinical validation of the Hemopurifier. The primary focus is the safety, feasibility, and dose-finding study in Australia for patients with solid tumors unresponsive to anti-PD-1 agents (like Keytruda or Opdivo). This is where the dollars are going. In fiscal 2025, clinical trial expenses associated with the Australian study increased by $467,000, which partially offset other cost savings. The goal is to generate the data needed for a potential Premarket Approval (PMA) study, the final hurdle for the FDA.

The Australian trial is moving forward. After treating the first three participants in Cohort 1 (January and June 2025), the independent Data Safety Monitoring Board (DSMB) recommended advancing to the second treatment cohort in July 2025. Recruitment for Cohort 2, which involves two Hemopurifier treatments per participant, is actively underway as of late 2025. To be fair, the company decided in August 2025 to stop pursuing a similar trial in India to focus all clinical resources on the Australian study for a more timely data readout.

Research and Development (R&D) of Hemopurifier Applications

R&D is a dual-track effort: supporting the oncology trial and exploring new indications. The preclinical work is key to expanding the Hemopurifier's potential. For instance, a May 2025 preclinical study demonstrated the device's proprietary resin removed approximately 98.5% of platelet-derived Extracellular Vesicles (EVs) from human plasma in a simulated 4-hour treatment. This result supports expanding the target indications beyond cancer to conditions like Long COVID, where a collaboration with the University of California, San Francisco (UCSF) is ongoing to analyze EV cargo from patient samples.

Manufacturing and Quality Control of the Device

As a clinical-stage medical device company, a key activity is maintaining a robust quality management system (QMS) and ensuring a reliable supply chain for the Hemopurifier devices used in trials. The company is actively evaluating the Hemopurifier's compatibility with a simplified blood treatment system, which would be a huge step for future commercialization and ease of use in oncology units. Furthermore, the company received a non-dilutive $218,000 R&D tax incentive credit from the Australian government in Q2 2026, which directly helps offset the cost of manufacturing and quality control for the trial devices used there.

Regulatory Affairs and Submissions Management

Regulatory affairs is a constant, high-priority activity. The Hemopurifier holds a U.S. Food and Drug Administration (FDA) Breakthrough Device designation, which helps streamline the development and review process. The company must continually manage its open Investigational Device Exemption (IDE) application with the FDA, which is the foundational regulatory pathway for its U.S. clinical studies. Getting the data, get the approval, period.

Intellectual Property (IP) Protection and Maintenance

Protecting the proprietary lectin-based technology is fundamental to the long-term business model. This involves continuous maintenance of existing patents and aggressive pursuit of new applications. The IP portfolio is a mixed bag of near-term and long-term protection:

What this estimate hides is the cost of defending patents, which can be substantial. The pending applications, which could extend protection to 2044, are critical for future value creation.

Here's the quick math: The focus on the Australian trial, coupled with the Q2 2026 operating expense reduction of 48%, shows a clear pivot to maximizing the runway of the remaining cash balance of approximately $5.8 million (as of September 30, 2025) to generate the necessary clinical data. The next step is clear: Finance must draft a 13-week cash view by Friday, modeling the burn rate against the Cohort 2 recruitment pace.

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Key Resources

In med-tech, resources are less about physical assets and more about intangible, high-value items. Their balance sheet is light on cash, so the Intellectual Property (IP) is the real anchor. Here's the quick math: the IP is the only thing keeping the valuation above the cash burn.

As of September 30, 2025, Aethlon Medical, Inc. (AEMD) held a cash balance of approximately $5.8 million. With consolidated operating expenses for the quarter ending September 30, 2025, at around $1.5 million, the company's runway is tight. This makes their intangible assets-the patents and regulatory approvals-the most critical resources they possess.

Patented Hemopurifier technology and IP portfolio

The patent portfolio is the company's lifeblood. The core technology is the Hemopurifier, an investigational medical device designed to remove enveloped viruses and tumor-derived extracellular vesicles (EVs) from circulation. This device uses a proprietary plant lectin resin, Galanthus nivalis agglutin (GNA), which is the key component that binds to the targets.

In 2025, they significantly expanded their IP coverage in infectious disease indications. For example, the U.S. Patent No. 12,409,260 for the treatment of Long COVID was set to issue in September 2025, and it is protected until 2042. A Unitary European Patent (No. 4136453) for COVID-19-associated coagulopathy (CAC) was issued in July 2025, expiring in 2041. These patents secure their exclusivity in two large, emerging therapeutic areas.

Scientific and clinical expertise (key personnel)

The company's human capital is concentrated in the scientific and regulatory leadership needed to navigate clinical trials. This expertise is a defintely necessary resource for a clinical-stage company. You can't outsource the core scientific understanding of a novel blood filtration mechanism.

Their scientific resource base is also extended through key partnerships. They maintain an active collaboration with the University of California San Francisco (UCSF) on Long COVID research, which is crucial for advancing their non-oncology indications and generating peer-reviewed data.

FDA Investigational Device Exemptions (IDEs)

Regulatory status is a non-physical resource that acts like a license to operate. The U.S. Food and Drug Administration (FDA) has granted the Hemopurifier a Breakthrough Device Designation for two distinct indications: advanced or metastatic cancer and life-threatening viruses not addressed by approved therapies. This designation provides an accelerated review pathway, which is invaluable in med-tech.

The company holds an open Investigational Device Exemption (IDE) application, allowing them to conduct clinical trials in the U.S. This is currently being utilized for an Early Feasibility Study (EFS) in oncology. The regulatory progress is summarized here:

Manufacturing supply chain for device components

While their balance sheet is light on physical assets, the ability to consistently manufacture the Hemopurifier cartridge is a critical operational resource. This requires a specialized supply chain for the proprietary resin and device assembly. Their focus is on efficiency, so any improvements here directly reduce the cash burn. For the fiscal year ended March 31, 2025, the total operating loss was $9.3 million, so every supply chain optimization helps them stretch their cash runway.

The company has initiated an evaluation of the Hemopurifier's compatibility with a simplified blood treatment system. That's a smart move to reduce the complexity and cost of deployment, which is a manufacturing resource optimization.

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Value Propositions

What Aethlon Medical, Inc. offers is a novel approach to treating complex diseases. It's a platform technology-a single device with multiple potential applications-which is a huge upside, but also a challenge for regulatory focus. They are selling hope backed by novel science.

The core value proposition centers on the Aethlon Hemopurifier, an investigational extracorporeal (outside the body) device that selectively removes pathogenic targets from the bloodstream. This is a crucial distinction: instead of a drug that targets a specific pathway, this device physically pulls harmful particles out of circulation. This is defintely a high-risk, high-reward model.

The device holds a U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for two separate, massive indications. This designation alone accelerates the review process, which is a major value-add for a clinical-stage company.

Oncology: Immunotherapy Response Enhancement

The most immediate and high-value proposition is in oncology. The Hemopurifier is designed to treat individuals with advanced or metastatic cancer who are unresponsive to or intolerant of standard-of-care immunotherapy, specifically anti-PD-1 agents like Pembrolizumab (Keytruda) or Nivolumab (Opdivo).

The thinking here is simple: tumor-derived extracellular vesicles (EVs), or exosomes, carry immunosuppressive signals like PD-L1 that essentially shield the cancer from the patient's own immune system and the immunotherapy drug. By removing these EVs, the Hemopurifier aims to 're-awaken' the body's immune response.

Initial exploratory data from the Australian oncology trial's first cohort showed promising early signals. For instance, a single 4-hour Hemopurifier treatment resulted in decreases in large EVs carrying PD-L1 in all three participants. Also, two of the three participants showed increases in total T cell counts, including tumor-specific T cells (CD137+). That's the kind of data that changes a decision.

Infectious Disease and Long COVID Mitigation

The second major value proposition is the device's broad-spectrum removal capability for enveloped viruses and other pathogenic targets. The Hemopurifier holds a Breakthrough Device Designation for life-threatening viruses not addressed by approved therapies.

This platform flexibility allows the company to pivot to emerging threats, like the ongoing collaboration with the University of California, San Francisco (UCSF) on Long COVID research. The market opportunity is significant: Long COVID affects an estimated 44 to 48 million people in the United States alone, with an estimated economic burden of $2 billion for those with symptoms lasting a year.

Preclinical data supports this viral and inflammatory target removal, showing the Hemopurifier removed 98.5% of platelet-derived extracellular vesicles (PD-EVs) in a simulated 4-hour treatment. PD-EVs are implicated in a wide range of diseases, including sepsis and Long COVID.

The Value Proposition in Numbers (Fiscal Year 2025 Context)

The value of the Aethlon Hemopurifier is currently measured in clinical milestones and financial runway, not commercial revenue, since they reported zero revenue growth in fiscal 2025. The value is in the potential. Here's the quick math on their operational discipline as they advance these propositions:

The value proposition is a two-pronged attack on critical care: one for oncology resistance, one for viral/inflammatory crises.

• Broad-spectrum removal of harmful particles from blood (e.g., viruses, exosomes).
• Potential treatment for cancers by removing immuno-suppressive exosomes (EVs).
• Mitigation of infectious disease threats (e.g., viral hemorrhagic fevers, Long COVID).
• Extracorporeal (outside the body) blood purification therapy, a non-drug, mechanical approach.

What this estimate hides is the long, costly path to a Premarket Approval (PMA) study required by the FDA for devices like this.

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Customer Relationships

For Aethlon Medical, Inc., the core of the Customer Relationship model right now is not sales-it's deep, consultative scientific validation and capital-raising. You're not selling a finished product; you're selling a vision and the data to back it up, so trust is the defintely the currency before revenue.

Given the Hemopurifier is an investigational medical device with a Breakthrough Device Designation from the FDA for two indications (cancer and life-threatening viruses), the relationship is highly personalized and requires continuous, hands-on scientific engagement. This isn't a transactional, automated model; it's a dedicated partnership with key stakeholders.

Highly Consultative and Scientific Engagement

The company's primary relationship is with the medical research community, which acts as the initial customer and validator. This involves a sustained, high-touch approach to ensure the integrity and progress of clinical trials. The focus is on generating the safety and feasibility data needed for a potential Premarket Approval (PMA) study.

For example, the ongoing Australian oncology trial is a safety, feasibility, and dose-finding study enrolling approximately 9 to 18 patients with solid tumors. The patient relationship is managed directly through the clinical investigators, requiring Aethlon Medical to maintain a close, supportive, and highly technical relationship with the hospital staff and lead physicians like Prof. Michael Brown.

Direct Relationship with Clinical Investigators and Key Opinion Leaders (KOLs)

Aethlon Medical relies on a small network of highly specialized experts and institutions to conduct its clinical work and validate its technology. This is a dedicated relationship model, not a self-service one. Here's the quick math on their current clinical footprint:

Any issue at one of these sites is a major risk to the entire program, so the communication must be constant and transparent. You can't afford a single misstep with these partners.

Investor Relations for Continuous Capital Raising

Because the company is pre-commercial, its other critical customer relationship is with investors-they are the primary source of revenue (capital) to fund operations. This necessitates a proactive, transparent, and frequent communication strategy via conference calls and public filings to maintain Nasdaq compliance and investor confidence.

This is a high-stakes relationship. For instance, the company announced a public offering in September 2025, which raised $4.5 million to support ongoing operations and clinical development. For the three months ended September 30, 2025 (Fiscal Q2 2026), the company's consolidated operating expenses were approximately $1.5 million, illustrating the direct link between investor capital and operational runway.

The company must continually justify its burn rate and clinical progress to keep the cash flowing. As of September 30, 2025, the cash balance was approximately $5.8 million.

Long-Term Commitment to Patient Outcomes

The ultimate goal is a successful therapeutic outcome, which is the only way to transition the customer relationship from 'clinical collaborator' to 'commercial buyer.' The relationship with the patient population is indirect but paramount, driven by the core promise of the Hemopurifier: a technology designed to remove cancer-promoting extracellular vesicles (EVs) and life-threatening viruses.

The relationship is defined by:

• Dedicated Personal Assistance: Direct support to clinical staff (investigators) to ensure proper device use and data collection.
• Co-Creation: Incorporating investigator feedback to amend protocols, such as the change to allow combination therapies in the Australian trial to broaden patient eligibility.
• Information & Trust: Regular investor calls (e.g., November 12, 2025) and press releases to maintain market trust in the clinical progress.

Your next step should be to track the Cohort 2 enrollment rate in Australia; that's your near-term indicator of clinical site engagement.

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Channels

The channels for the Hemopurifier are defintely not a commercial sales pipeline yet; they are a highly specialized, research-driven network. The current channel is the clinical trial site, which is the sole point of delivery for the device's value proposition-safety and efficacy data-to its primary customer: the regulatory bodies and the medical community. You must view the company as selling its data, not its product, right now.

Current Primary Channel: Clinical Research Sites

The Hemopurifier reaches patients exclusively through a tightly controlled network of world-class clinical research centers. This is a direct-to-specialist channel, even in the pre-commercial phase, focusing on complex oncology and infectious disease applications. Right now, the channel is the clinic.

• Australian Oncology Trial: The core delivery channel is the Phase 1 safety, feasibility, and dose-finding study in Australia for solid tumors unresponsive to anti-PD-1 therapy. Recruitment for Cohort 2 is underway as of late 2025.
• Key Sites: Treatments have been administered at sites like the Royal Adelaide Hospital and Royal North Shore Hospital in Sydney. The company is actively working to onboard a third Australian medical center to accelerate patient enrollment.
• Indian Expertise: The channel also includes Medanta Medicity Hospital in India, where the company received regulatory approval in fiscal 2025 to initiate a similar oncology study. This site is crucial because its neurologists are considered the world's experts in using the Hemopurifier, having completed approximately 120 human treatments previously.

Market Access Channel: Regulatory Milestones

The regulatory pathway is the most critical channel for future commercialization, as it dictates market access and speed. The company has secured an important advantage in the U.S. that will streamline the later stages of development.

• U.S. FDA: The Hemopurifier holds a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for specific oncological and viral indications. This designation is a fast-track channel, allowing for more interactive and timely communication with the FDA, which should accelerate the clinical development and review process.
• Global Approvals: Regulatory approval was secured in India during fiscal 2025 to initiate the oncology study, opening a secondary clinical channel in a major market.

Scientific & Awareness Channel: Publications and Conferences

To build credibility and drive future adoption, the company uses scientific communication channels to reach key opinion leaders (KOLs) and the broader medical community. This is how the device moves from a clinical trial concept to a peer-validated technology.

• Peer-Reviewed Data: Findings from a preclinical study showing the Hemopurifier's ability to remove 98.5% of platelet-derived extracellular vesicles (EVs) were published in a peer-reviewed journal in February 2025.
• Research Collaboration: An ongoing collaboration with the University of California, San Francisco (UCSF) Long COVID Clinic is a key channel for exploring new indications, with a manuscript in preparation for a peer-reviewed journal.
• Conference Presentations: The company used the Keystone Symposium on Long COVID in August 2025 to present an abstract on the device's affinity resin, directly targeting researchers in the post-acute infection space.

Channel Cost Analysis: FY 2025 Financials

The cost structure of the current channel is entirely R&D-focused. The financial data from fiscal 2025 (FY 2025 ended March 31, 2025) clearly maps the expense of running this clinical channel. The operating loss for the fiscal year was $9.3 million. Here's the quick math on the direct channel costs.

What this estimate hides is the significant cost reduction-a 48% drop in consolidated operating expenses to $1.5 million in Q2 2025-which extends the runway for the clinical channel, but it also reflects a lower headcount and reduced non-clinical activity. The Australian government's R&D program, which returns up to 43 cents on the dollar of money spent on the trial, is a crucial financial channel supporting the clinical sites.

Next Step: Strategy Team: Model the projected cost and timeline for establishing a direct sales force to specialized oncology centers post-FDA approval (PMA study completion).

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Customer Segments

You're looking at Aethlon Medical, Inc. (AEMD) and its customer base, and you need to remember that for a clinical-stage company, the immediate customer isn't the patient; it's the gatekeeper. The company is pre-commercial, so its current revenue for the fiscal year 2025 (ending March 31, 2025) was $0.00, meaning the customer relationship is purely focused on research and regulatory advancement right now. The real customers are the clinical sites and researchers who validate the Aethlon Hemopurifier, which then unlocks access to the ultimate end-users: patients with few other options.

The strategic focus is on niche, high-unmet-need areas where the Hemopurifier's mechanism-removing tumor-derived extracellular vesicles (EVs) and enveloped viruses-offers a novel therapeutic pathway. That's a smart, focused approach. The company had a cash balance of approximately $5.8 million as of September 30, 2025, which funds this highly targeted clinical strategy.

Clinical Investigators and Research Institutions

This group represents the company's primary, near-term customer. They are the ones purchasing or receiving the device for use in trials, generating the data Aethlon Medical, Inc. needs for regulatory approval. They are motivated by access to novel technology for patients who have failed standard care, plus the prestige and funding associated with leading-edge research. The Australian oncology trial is a perfect example, with sites like Royal Adelaide Hospital and Royal North Shore Hospital actively recruiting for Cohort 2 as of late 2025. Also, the collaboration with the University of California, San Francisco (UCSF) on Long COVID research places academic institutions squarely in the customer segment.

Oncologists Treating Advanced-Stage Cancers

The ultimate customer here is the patient population with advanced or metastatic solid tumors who are unresponsive to or intolerant of anti-PD-1 agents like Pembrolizumab (Keytruda) or Nivolumab (Opdivo). This is a critical, high-value segment because the current standard of care fails roughly 60% to 70% of patients who receive these immunotherapies. The Hemopurifier is positioned as a way to potentially restore immune response by clearing tumor-derived EVs, which are believed to contribute to drug resistance. The ongoing trial in Australia, and the similar one approved in India at Medanta Medicity Hospital, directly target this specific, desperate patient need.

Critical Care Physicians Managing Severe Viral Infections

This segment focuses on the Hemopurifier's second FDA Breakthrough Device Designation: the treatment of life-threatening viruses not addressed with approved therapies. The customer is the critical care physician in a hospital setting who needs a broad-spectrum, rapid intervention for an emerging or highly lethal viral threat. While the company's current R&D is heavily weighted toward oncology, the preclinical work and UCSF collaboration on Long COVID show a clear path to this customer. Long COVID alone affects an estimated 44 to 48 million people in the United States, representing a significant future market opportunity for this segment.

Government Health and Biodefense Agencies

This is a strategic customer segment, often driven by biodefense and pandemic preparedness needs, rather than immediate clinical sales. The company has a history of government contracting, including a past contract extension with the Defense Advanced Research Projects Agency (DARPA) for developing a biofiltration device to treat sepsis. While the cited contract is older, the capability remains a key asset. The two FDA Breakthrough Device designations for life-threatening viral infections and cancer are powerful signals to agencies like the Biomedical Advanced Research and Development Authority (BARDA) that the technology is a serious candidate for national security and public health stockpiling. This segment is less about day-to-day sales and more about large, non-dilutive funding opportunities.

Here's the quick math on the current and potential customer segments:

The company is defintely targeting the right pain points, where existing treatments fall short.

The next concrete step is for the Clinical Operations team to secure full enrollment for the Australian Cohort 2 by the end of the calendar year to keep the data flow on track.

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Cost Structure

Aethlon Medical, Inc. is a classic R&D-heavy biotech company. Its cost structure is dominated by personnel and clinical trial expenses, leading to a significant burn rate that requires constant financing. The good news is, you've seen a sharp pivot toward cost discipline in late 2025.

The core of Aethlon's cost is fixed, tied to maintaining its clinical program and corporate compliance, with minimal variable costs since product sales are negligible. This means every dollar saved on overhead directly extends the cash runway. They've been aggressive about this, cutting consolidated operating expenses for the full Fiscal Year (FY) 2025 (ended March 31, 2025) to approximately $9.3 million, a solid drop from $12.6 million in the prior year.

Research and Development (R&D) and Clinical Trial Costs

This is the engine of a development-stage biotech, and it's where the majority of capital goes. For Aethlon, R&D and clinical trial costs are intrinsically linked to the progress of the Hemopurifier in its oncology and infectious disease programs.

The company is concentrating its limited resources, which is smart. They canceled a planned trial in India to focus exclusively on the Australian oncology trial. While total operating expenses are down, the direct cost of the Australian study is still a major factor; for the full FY 2025, clinical trial expenses actually saw an increase of approximately $467,000, reflecting the ramp-up of the oncology study.

However, the cost of the Australian trial is partially mitigated. The company expects a significant 43% cash rebate on project costs from the Australian government, which is a crucial offset to their burn rate.

General and Administrative (G&A) Overhead

G&A is typically the easiest place to cut, and Aethlon has been relentless here. The goal is to keep the lights on and the compliance running with the smallest possible team. In the most recent quarter, Q2 FY 2026 (ended September 30, 2025), consolidated operating expenses were approximately $1.5 million, a 48% decrease year-over-year.

The cuts are deep and specific:

• Payroll and Related Expenses: Decreased by approximately $778,000 in Q2 FY 2026 due to lower headcount and reduced bonus accruals.
• General and Administrative Expenses: Declined by approximately $437,000 in Q2 FY 2026.
• Professional Fees: Decreased by approximately $177,000 in Q2 FY 2026, mainly from reduced investor relations and contract labor.

That's a clean one-liner: They are managing their burn rate down to the bone.

Near-Term Cash Runway and Risk

The cost structure translates directly into a tight cash runway, which is the defintely the biggest near-term risk. As of September 30, 2025, Aethlon had a cash balance of approximately $5.8 million. With a quarterly operating expense of roughly $1.5 million, the runway is currently extended beyond the two quarters it had earlier in the year, but it still necessitates additional capital raising within the next three to six months to fund the next stages of the Australian trial and other R&D.

Here's the quick math on the quarterly burn breakdown for Q2 FY 2026 (ended September 30, 2025):

IP Maintenance and Legal Fees

While professional fees are down overall, the line item for legal, tax, audit, and financial services costs has actually increased, partially offsetting the reduction in other professional fees. This is a necessary cost for a biotech, as maintaining a global Intellectual Property (IP) portfolio for the Hemopurifier and ensuring regulatory compliance (like the recent Nasdaq compliance resolution) are non-negotiable fixed costs. The company's recent change in law and accounting firms was a strategic move to lower these ongoing professional fees, but the core legal cost of protecting the technology remains a critical, unavoidable expense.

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Revenue Streams

You're looking at Aethlon Medical, Inc. (AEMD) and the revenue picture is stark: the company is pre-commercial, so its actual revenue streams are minimal and non-recurring. The entire valuation rests on future, high-margin product sales that require successful regulatory approval of the Hemopurifier.

The current revenue structure is not a true business model but a financial survival strategy. It's a mix of non-dilutive funding, minimal product sales, and, most importantly, capital raises to bridge the gap to commercialization. Honestly, the cash burn is the most important number right now.

Current Revenue Sources (Fiscal Year 2025)

A pre-commercial biotech company like Aethlon Medical earns money from a few distinct, non-operational sources. For the fiscal year ended March 31, 2025, the company reported $0.0 in annual product revenue, meaning no meaningful sales of the Hemopurifier (therapeutic blood filtration system) have occurred yet.

The minimal income that did come in was primarily from non-operational sources, which are critical for funding ongoing research and development (R&D) and clinical trials. This is where the company buys time.

• Government grants and contracts: Funding from agencies like the National Institutes of Health (NIH) or Department of Defense (DoD) to support specific research projects.
• Minimal product sales: Primarily from compassionate use cases or research-only sales, which are not a sustainable commercial stream.
• Capital raises (equity/debt financing): The essential, recurring stream to fund operations, involving selling company stock or issuing debt.

Here's the quick math on the non-operational income for the 2025 fiscal year. The company recognized approximately $360,789 in total other income. This included $324,450 from the Employee Retention Tax Credit (ERTC) and $36,339 in interest income.

The operational reality is that the company's operating loss for the fiscal year ended March 31, 2025, was approximately $9.3 million, while the net loss attributable to common stockholders was approximately $13.39 million. That's a significant gap to fill with financing.

Future Revenue Stream: High-Margin Device Sales

The primary, high-potential revenue stream is the future commercial sale of the Hemopurifier. This is a classic biotech bet: low-to-no revenue now for a massive payoff later. The device is a therapeutic blood filtration system designed to remove harmful exosomes and viruses, targeting indications like cancer and infectious diseases (e.g., Long COVID).

The current clinical progress is the leading indicator for this future stream. The company is advancing its oncology trial in Australia and has received Indian regulatory approval to initiate a similar study. This work is setting the stage for a high-margin, recurring revenue model based on device and disposable cartridge sales, but it's still years away.

The future revenue model will be based on a high-value, per-treatment fee structure, likely involving a capital sale of the Hemopurifier machine to hospitals or clinics, plus the ongoing, high-margin sale of single-use disposable cartridges for each patient treatment. If onboarding takes 14+ days, churn risk rises.

• Capital equipment sales: One-time sale of the Hemopurifier system to healthcare facilities.
• Disposable cartridge sales: Recurring, high-margin revenue from the single-use cartridges used in each patient treatment.
• Licensing and collaboration fees: Potential revenue from partnerships with larger pharmaceutical or medical device companies for regional rights or co-development.

The commercial opportunity is substantial, with the Long COVID market alone estimated to affect 44 to 48 million people in the United States, representing a significant unmet medical need. But until a major regulatory milestone is hit, the revenue stream remains an unfunded promise.