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Here are a few analogies for Aethlon Medical (AEMD):

• Fresenius Medical Care for filtering cancer and viral elements from blood.
• Gilead Sciences, but developing a blood purification device instead of drugs to fight cancer and viruses.

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• Hemopurifier®: A medical device designed for broad-spectrum extracorporeal blood purification, aiming to remove circulating viruses and immunosuppressive exosomes implicated in cancer progression and infectious diseases.

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Major Customers of Aethlon Medical (AEMD)

Aethlon Medical (AEMD) is primarily a research and development-stage company focused on its investigational medical device, the Hemopurifier. As such, it does not have major commercial customers in the traditional sense, as its product is not yet approved for widespread commercial sale by regulatory bodies like the FDA.

Instead, Aethlon Medical's activities involve collaboration with, and funding from, various institutions for clinical trials, compassionate use programs, and research and development initiatives. The primary entities that interact with Aethlon Medical's technology or fund its development, serving as its de facto "major customers" or key partners in its current stage, are primarily other institutions rather than individuals.

• Government Agencies: These agencies often provide grants and contracts to Aethlon Medical for research and development, and for specific initiatives related to public health threats. They act as critical funders and partners in advancing the Hemopurifier.
  • National Institute of Allergy and Infectious Diseases (NIAID): A component of the National Institutes of Health (NIH), NIAID has provided significant funding and contracts to Aethlon Medical for the development and evaluation of the Hemopurifier, particularly in the context of infectious diseases. (NIAID is a U.S. government agency, not a public company, so no stock symbol applies).
  • Department of Defense (DoD): The DoD has also supported Aethlon Medical's technology development through grants and contracts for applications relevant to military health and biodefense. (The DoD is a U.S. government entity, not a public company, so no stock symbol applies).
• Hospitals and Academic Medical Centers: These institutions serve as clinical trial sites and providers for compassionate use cases of the investigational Hemopurifier. They are key to gathering clinical data and making the device available under specific regulatory frameworks.
  • UC San Diego Health: Has been a prominent site for clinical trials involving the Hemopurifier, including studies related to COVID-19 and other critical conditions. (UC San Diego Health is part of the University of California system, not a public company, so no stock symbol applies).
  • Cedars-Sinai Medical Center: Has also been involved in clinical studies and investigational use of the Hemopurifier. (Cedars-Sinai is a non-profit academic medical center, not a public company, so no stock symbol applies).
  • Other academic medical centers and hospitals participating in ongoing or past clinical trials or compassionate use programs.

While these entities are crucial to Aethlon Medical's operations and development, they are not typically "customer companies" making commercial purchases of an approved product. They are partners, funders, or sites for the investigational use of Aethlon's technology.

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James B. Frakes, Chief Executive Officer and Chief Financial Officer

Mr. Frakes was appointed permanent Chief Executive Officer of Aethlon Medical in October 2024, having served as Interim CEO since November 2023. He has also been the Chief Financial Officer since January 2008. He possesses 27 years of CFO-level financial responsibility for publicly traded companies. His prior experience includes CFO positions at Left Behind Games Inc. and NTN Buzztime, Inc. Mr. Frakes has expertise in equity and debt transactions, acquisitions, public reporting, and Sarbanes-Oxley section 404 internal control requirements. He holds an MBA from the University of Southern California and a BA with Honors from Stanford University.

Steven LaRosa, M.D., Chief Medical Officer

Prior to joining Aethlon Medical, Dr. LaRosa served as the Vice President of Clinical Development at Entasis Therapeutics, a spin-out of AstraZeneca, where he led the clinical development of multiple programs, including two in Phase III clinical trials. His background also includes roles as an Attending Physician and Antimicrobial Stewardship Director at Beverly Hospital and Assistant Professor of Medicine at Brown Medical School. He co-founded and directed the Ocean State Clinical Coordinating Center (OSCCC), an academic Contract Research Organization (CRO) that collaborated with industry sponsors on clinical trials. Earlier in his career, he was a Staff Physician at the Cleveland Clinic Foundation, a Principle Investigator on numerous sepsis clinical trials, and a Clinical Research Physician at Eli Lilly and Company, where he led the Phase III clinical trial for recombinant human activated Protein C (Xigris). Dr. LaRosa earned his M.D. from Boston University School of Medicine.

Michele Bombardiere, Vice President, Controller

Ms. Bombardiere is a strategic finance, accounting, and operations leader with over 25 years of experience in both public and private companies, including time in the consulting division of Price Waterhouse (now PwC). She has held key senior and executive positions, demonstrating proficiency in financial analysis, process streamlining, driving operational efficiency, and managing cross-functional teams. Her experience extends beyond finance and accounting to include operations, technology, and customer engagement, and she has played a significant role in securing funding, supporting strategic acquisitions, and enhancing business results. She holds a Bachelor of Science in Financial Management from Clemson University.

John Nguyen, Vice President of Manufacturing

Mr. Nguyen is an operations and technical leader with 25 years of experience in the biotech and life sciences sectors. His expertise encompasses developing and manufacturing medical devices, establishing scalable team structures, and managing product lines and high-profile projects, with a focus on implementing process improvements and cost savings.

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1. Financial Health and Going Concern: Aethlon Medical faces significant financial challenges, including a history of operating losses and zero revenue growth. The company's profitability ratios, such as operating margin, net margin, return on equity (ROE), return on assets (ROA), and return on invested capital (ROIC), are all negative. These indicators, coupled with statements expressing "substantial doubt about its ability to continue as a going concern for 12 months," highlight a precarious financial position. While the company has a cash balance, it may not be sufficient to support operations without additional financing, and its sustainability relies heavily on careful cost control and potentially securing future government funding.

2. Clinical Trial Dependence and Regulatory Approval: The company's future hinges on the successful development and regulatory approval of its primary product, the Hemopurifier, an investigational medical device. Aethlon is conducting clinical trials, particularly in oncology and for Long COVID applications, and faces risks such as slow patient enrollment in ongoing trials (e.g., the Australian oncology trial). The inherent uncertainties and challenges associated with clinical trials, including the need to demonstrate both the utility and safety of the device, present a significant hurdle. Obtaining necessary approvals from regulatory bodies like the FDA is critical for the commercialization and market viability of the Hemopurifier.

3. Nasdaq Listing Compliance and Stock Volatility: Aethlon Medical has experienced significant stock price volatility, with a beta of 2.03 indicating it is more volatile than the market. The company recently underwent a 1-for-10 reverse stock split to regain compliance with Nasdaq's minimum bid price rule. Failure to maintain compliance with Nasdaq listing requirements could lead to delisting, further impacting investor confidence and the company's ability to raise capital.

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Aethlon Medical (AEMD) is developing the Hemopurifier, a clinical-stage immunotherapeutic device with applications in cancer, life-threatening viral infections, and potentially organ transplantation.

Addressable Markets for Aethlon Medical's Main Products or Services:

• Cancer Treatment (targeting cancer-promoting exosomes):
  • Global Oncology Market: Expected to reach $220 billion by 2030.
  • U.S. Exosomes Market (for cancer applications): This segment accounted for 32.0% of the U.S. exosomes market, which was estimated at $73.58 million in 2023.
• Life-Threatening Viral Infections (including Long COVID, targeting circulating viruses and extracellular vesicles):
  • U.S. Long COVID Market (economic burden): The annual economic burden in the U.S. due to Long COVID was $218 billion in 2023.
  • Global Long COVID Market (economic losses): Global economic losses from Long COVID could reach $1 trillion annually. The market for therapies is currently underserved.
  • U.S. Exosomes Market (for infectious diseases applications): This segment is anticipated to grow at a Compound Annual Growth Rate (CAGR) of 35.0% from 2024 to 2030.
• Sepsis (biofiltration device for treatment):
  • Global Sepsis Diagnostics Market: Valued at $918.0 million in 2024 and projected to grow to $1,953.6 million by 2032, exhibiting a CAGR of 10.0% from 2025 to 2032.
  • U.S. Sepsis Diagnostics Market: Projected to reach $950.5 million by 2032.
• Organ Transplantation:
  • Market Size: null

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Aethlon Medical (AEMD) anticipates several key drivers for future revenue growth over the next two to three years, primarily centered on the continued development and expansion of its Hemopurifier device:

1. Advancement and Commercialization of Hemopurifier in Oncology: Aethlon Medical is focused on its ongoing clinical trial in Australia, evaluating the Hemopurifier in cancer patients with solid tumors who are unresponsive to anti-PD-1 therapies. The company has completed the first cohort with positive safety results and is progressing to the second cohort. The completion of this Australian oncology trial is anticipated by late 2025 or early 2026, which could lead to applications for Pre-Market Approval (PMA) or efficacy trials, paving the way for commercialization in this significant market.
2. Expansion into the Long COVID Market: Aethlon Medical is actively conducting preclinical research and collaborating with the University of California, San Francisco (UCSF) Long COVID Clinic to explore the Hemopurifier's application in treating Long COVID. Preclinical studies have demonstrated the device's ability to remove platelet-derived extracellular vesicles (PD-EVs), which are implicated in the pathogenesis of Long COVID. This initiative targets a large unmet medical need and presents a substantial new market opportunity for the Hemopurifier.
3. Broader Application and Regulatory Approval for Other Exosome-Associated Diseases and Life-Threatening Infectious Diseases: The Hemopurifier is designed to remove harmful exosomes and life-threatening viruses from the bloodstream. This core technology has broad potential beyond cancer and Long COVID, encompassing various exosome-associated conditions and other life-threatening infectious diseases. The company is committed to pursuing regulatory approval and "unlocking its potential across multiple disease areas," suggesting a strategy to leverage the device's versatility for a wider range of medical applications.

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Share Issuance

• Aethlon Medical closed a public offering on May 17, 2024, generating approximately $4.7 million in gross proceeds from the sale of 2,450,000 shares of common stock and accompanying Class A and Class B warrants, and pre-funded warrants to purchase an additional 5,650,000 shares at a combined price of $0.58 per share and warrants.
• In September 2025, the company priced another public offering, expecting to raise approximately $4.5 million in gross proceeds from the sale of 5,000,000 shares of common stock (or pre-funded warrants) and warrants to purchase up to 5,000,000 shares at a combined price of $0.90 per unit.
• During the three months ended June 30, 2021, Aethlon Medical raised approximately $17.5 million in net proceeds through the issuance of common stock from a registered direct financing and at-the-market (ATM) sales.

Capital Expenditures

• A substantial portion of Aethlon Medical's operating budget is allocated to research and development (R&D) activities, with costs amounting to approximately $2,520,000 in fiscal year 2024 and $2,745,000 in fiscal year 2023.
• These R&D expenses include costs associated with manufacturing additional Hemopurifiers for clinical trials.
• Future capital requirements are anticipated to be driven by progress in pre-clinical testing and clinical trials, the expansion of clinical programs, and the time required for regulatory approvals.