Aethlon Medical Reports FY 2024 Financial Results and Corporate Update

Aethlon Medical, Inc., a company specializing in medical therapeutics for cancer and infectious diseases, has disclosed its financial results for the fiscal year ending March 31, 2024, and provided updates on recent advancements.

Aethlon Medical is actively pursuing the development of its Hemopurifier® technology, a blood filtration system engineered to remove harmful exosomes and life-threatening viruses from biological fluids. The Hemopurifier holds promise for applications in oncology by potentially mitigating immune suppression and metastasis caused by cancer-associated exosomes, as well as in the treatment of severe infectious diseases. Additionally, the company is exploring the device's use in organ transplantation, particularly for the removal of viruses and exosomes from recovered kidneys.

On June 18, 2024, the Human Research Ethics Committee (HREC) of the Central Adelaide Local Health Network (CALHN) granted ethics approval for Aethlon’s clinical trial of the Hemopurifier in cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatments, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab). The trial, set to be conducted by Prof. Michael Brown and his team at the Royal Adelaide Hospital in Australia, has a three-year approval window until June 13, 2027.

Notably, only about 30% of patients treated with pembrolizumab or nivolumab show lasting clinical responses. Tumor-produced extracellular vesicles (EVs) are suspected of spreading cancer and causing resistance to these therapies. The Hemopurifier aims to bind and remove these EVs from the bloodstream, potentially improving the efficacy of anti-PD-1 treatments. Preclinical studies have already shown the device's ability to reduce exosome levels in cancer patient samples.

James Frakes, Aethlon Medical’s Interim CEO and CFO, highlighted the significant progress made in advancing the Hemopurifier’s clinical trials in Australia and India, especially with the recent approval from the CALHN Ethics Committee. Following submissions to the Therapeutic Goods Administration and approvals from the CALHN Research Governance Committee, the company anticipates enrolling and treating the first patient in either the September or December quarter of 2024. 

In April 2024, the U.S. FDA approved Aethlon’s internal manufacturing facility, marking another milestone for the company. Frakes also mentioned upcoming milestones, including submissions to additional ethics committees at two sites in Australia and one in India. Approvals from these institutions are expected potentially by the September quarter of 2024, with patient enrollment at these sites anticipated by the end of 2024.

The primary endpoint of the Hemopurifier trial, involving approximately 18 patients, is to ensure safety. The study will monitor adverse events and significant lab test changes in patients with stable or progressive solid tumors. Patients unresponsive to PD-1 antibody therapy will enter the Hemopurifier phase, receiving 1 to 3 treatments over a week. The trial also seeks to determine if reducing EV concentrations can enhance the body’s natural tumor-fighting abilities. These findings will guide future efficacy and safety trials, including those required by the FDA.

Aethlon Medical is also maintaining momentum in its COVID-19 trial in India, with sites at Medanta Medicity Hospital and Maulana Azad Medical College. Although only one patient has been treated so far, the trial remains open in case of new COVID-19 admissions. The company is also monitoring the multi-state outbreak of H5N1 Avian Influenza, noting the Hemopurifier's past success in capturing earlier H5N1 strains, though not yet tested against the current strain.

Financially, as of March 31, 2024, Aethlon Medical had a cash balance of approximately $5.4 million, which increased to $9.1 million by June 25, 2024. The fiscal year saw consolidated operating expenses of around $12.6 million, a slight increase from $12.5 million the previous year. This rise was attributed to higher payroll expenses, partially offset by reductions in general administrative and professional fees. Consequently, the net loss for the fiscal year increased to $12.2 million from $12.0 million in the previous year.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!