Aethlon Medical (AEMD) investor relations material

Product overview and clinical focus

• Hemopurifier is an extracorporeal device designed to remove viruses and cancer-related extracellular vesicles from the bloodstream, compatible with standard hospital blood-pumping equipment.

• Initially targeted at viral infections like HIV, Hepatitis C, COVID, and Ebola, the main focus has shifted to oncology, specifically solid tumors unresponsive to anti-PD-1 therapies.

• The device has treated 44 patients in 173 sessions, showing a strong safety profile with only minor side effects and procedural improvements over time.

• The current trial is a three-cohort, dose-escalation safety and feasibility study in patients with solid tumors not responding to immunotherapy.

• The hypothesis is that removing extracellular vesicles may improve response rates to immunotherapies and slow metastasis.

Clinical trial progress and milestones

• First and second cohorts have been completed without dose-limiting toxicities; a Data Safety Monitoring Board meeting in March will determine progression to the third cohort.

• Key upcoming milestones include the March safety board meeting, central lab data on device efficacy within two months, and completion of the third cohort.

• Patient recruitment has accelerated through digital outreach and pre-screening, resulting in a pipeline of qualified candidates for the third cohort.

• The trial is conducted in Australia, leveraging a 43% cash rebate on clinical expenses and strong local partnerships.

• Data from the trial will be used for regulatory engagement in both Australia and the U.S., with Breakthrough Device designations already granted by the FDA.

Strategic initiatives and financial position

• Early-stage discussions are ongoing with potential strategic or pharmaceutical partners, pending further clinical data.

• The company holds approximately $7 million in cash, with a monthly burn rate of $500,000, and access to an additional $1.8 million through an at-the-market offering.

• Current funding is expected to support completion of the ongoing trial, with future financing or partnerships needed for commercialization.

• The addressable market is significant, with Keytruda alone representing $25 billion annually; the company aims for a unique niche targeting non-responders to immunotherapy.

• The SLAM platform is being evaluated to simplify treatment delivery, potentially expanding the addressable market and improving patient experience.