AETHLON MEDICAL INC

Aethlon Medical, Inc.

Company overview

• Clinical-stage medical therapeutics company developing the Hemopurifier® (HP), an extracorporeal device designed to bind and remove enveloped viruses and extracellular vesicles (EVs) from plasma.
• HP uses a proprietary lectin-based affinity technology and is being evaluated for oncology (removal of tumor-derived EVs), life-threatening viral infections, organ transplantation including organ perfusion applications, and other disease states where EVs contribute to progression.
• Regulatory status:
  • In the U.S., HP is treated as a combination product with primary FDA premarket considerations in the Center for Devices and Radiological Health (CDRH).
  • The device is being developed under an FDA Investigational Device Exemption (IDE) with an open IDE program for viral indications.
  • HP has received Breakthrough Device designation for two indications: an oncology indication (advanced/metastatic cancer unresponsive to standard therapy) and a life‑threatening viral indication not addressed by approved therapies.
  • The company has not obtained FDA or foreign regulatory clearance/approval to commercially market HP; ongoing clinical trials are the path to potential approval.

Technology, product, and development focus

• Hemopurifier device
  • Purpose: remove enveloped viruses and disease-associated EVs from plasma to address cancer and infectious disease indications; also explored for organ preservation/perfusion.
  • Configuration: designed to operate with approved dialysis machines or as a closed‑system device with its own pump and tubing.
  • Manufacturing: cGMP-compliant scaling planned. Manufacturing moved to the company’s San Diego facility in May 2024. A second supplier for the GNA lectin is being qualified; FDA action is required to switch suppliers for that component. Three critical components currently have a limited number of suppliers.
• Clinical development programs
  • Oncology (Australia): safety, feasibility, and dose‑finding study in solid tumors in combination with anti‑PD‑1 monotherapy; planned enrollment ~9–18 participants. During fiscal 2026, the first cohort (3 participants) completed enrollment and treatment; the second cohort was initiated and then advanced to a third cohort with DSMB approval. To date, there have been no serious adverse events or dose‑limiting toxicities attributed to HP in this program.
  • India oncology: a CDSCO-approved study (July 2025) was evaluated but not pursued to conserve resources; focus shifted to the Australia program.
  • Viral infections: prior clinical work includes studies in Ebola, HIV, hepatitis C, and SARS‑CoV‑2. An open IDE for viral indications remains active. Prior COVID‑19 feasibility studies in the U.S. and India included one patient in each country; outcomes were mixed and inconclusive for efficacy.
• Other exploration
  • Preclinical and translational studies on EV removal in organ perfusion and related ex vivo research have been published to support broader therapeutic exploration.

Manufacturing and supply chain

• Key components with limited suppliers:
  • GNA lectin: current source Vector Laboratories, Inc.; alternate suppliers available but FDA action required to qualify a switch.
  • Base cartridge: Medica S.p.A. (limited supplier).
  • Diatomaceous earth: distributed by Janus Scientific, Inc.; manufactured by Imerys Minerals Ltd. (single‑source risk).
• The company depends on a small number of suppliers for critical components and must obtain regulatory approval to qualify alternate sources.

Intellectual property and licensing

• Patent portfolio: approximately 19 issued U.S. patents and about 18 pending U.S. and international applications covering extracorporeal removal technologies, viral and exosome applications, and related methods. Issued patents are scheduled to expire between 2027 and 2031, subject to extensions.
• Licensing: the company owns or exclusively licenses several patents and holds licenses from third parties for certain cancer‑related uses and components, including assignments from London Health Science Centre Research, Inc.
• The company identifies the usual risks associated with patent validity, enforceability, potential claim scope changes, and third‑party challenges.

Regulatory and commercialization context

• HP is not approved for sale in the U.S. or other jurisdictions. Pathways to market include PMA for Class III devices or other regulatory clearances, requiring substantial preclinical, clinical, and manufacturing data.
• Post‑approval obligations may include quality system regulation (QSR) compliance, device reporting, and post‑market surveillance.
• Breakthrough Device designation provides priority review considerations for designated indications but does not guarantee approval or shortened timelines.

Financials and operations

• Revenue and customers:
  • No revenue for the fiscal years ended March 31, 2026 or March 31, 2025.
  • No commercial customers; the company remains in clinical development.
• Clinical exposure: prior human studies comprise 173 treatment sessions in 44 patients across viral infection and oncology indications.
• Employees: 9 full‑time employees as of June 8, 2026.
• Cash and financing:
  • Cash and cash equivalents as of March 31, 2026: approximately $5.5 million.
  • Subsequent to March 31, 2026, the company sold 800,111 common shares under its at‑the‑market facility for gross proceeds of about $1.904 million (net approximately $1.851 million after commissions and SEC‑related costs; offering‑related costs not fully recorded).
  • The company expects to use available cash for working capital, clinical development, and R&D.
• Research and development expense: approximately $1.912 million for fiscal 2026 and $2.212 million for fiscal 2025.
• Going‑concern: the company states there is substantial doubt about its ability to continue as a going concern within 12 months after issuance of the financial statements, driven by the need for additional financing and the absence of current revenue. The company intends to pursue equity and other funding, which could dilute existing shareholders.

Corporate and governance

• The company is subject to Nasdaq listing requirements and discloses risks related to potential delisting if listing standards are not maintained.
• Corporate governance is Nevada‑based and includes forum selection provisions and bylaw provisions that affect stockholder actions and related defenses.
• Public company costs and obligations are identified as material demands on limited resources.

Summary

Aethlon Medical, Inc. is advancing the Hemopurifier, a lectin‑based extracorporeal device designed to remove enveloped viruses and extracellular vesicles from plasma. The company is clinical‑stage with active oncology trials in Australia, prior viral infection studies, manufacturing at its San Diego facility, a defined but limited supplier base for critical components, and an IP portfolio of issued and pending patents. The company remains pre‑commercial, reports no revenue, has limited cash on hand as of March 31, 2026, and identifies financing and regulatory milestones as key near‑term needs.