Aethlon Medical Reports Q1 2024 Financial Results and Corporate Update

Aethlon Medical, Inc., a company dedicated to developing therapeutic solutions for cancer and severe infectious diseases, has revealed its financial outcomes for the fiscal first quarter ending June 30, 2024. The company provided updates on its ongoing projects, including significant advancements in the use of its Hemopurifier® device.

The Hemopurifier® is a blood filtration device designed to eliminate harmful exosomes and viruses from blood and other bodily fluids. This technology has potential applications in oncology, infectious diseases, and organ transplantation. The device has shown promise in preclinical studies, demonstrating an ability to reduce the number of extracellular vesicles (EVs) in plasma samples from cancer patients, which may enhance the effectiveness of anti-PD-1 antibodies used in cancer treatment.

On August 12, 2024, the Bellberry Human Research Ethics Committee approved a safety, feasibility, and dose-finding clinical trial of the Hemopurifier® at Pindara Private Hospital in Queensland, Australia. This trial targets patients with solid tumors who show stable or progressive disease during anti-PD-1 monotherapy treatments, including Merck's Keytruda® (pembrolizumab) and Bristol Myers Squibb’s Opdivo® (nivolumab). The approval is valid for one year, expiring on August 6, 2025, and will be conducted by Dr. Marco Matos and his team.

Earlier, on June 18, 2024, the Human Research Ethics Committee of the Central Adelaide Local Health Network also granted approval for an identical trial at the Royal Adelaide Hospital, supervised by Prof. Michael Brown. This approval is valid until June 13, 2027. These trials aim to determine the safety and appropriate dosage of the Hemopurifier® in cancer patients who do not respond adequately to anti-PD-1 therapies.

Approximately 30% of patients respond positively to anti-PD-1 treatments like pembrolizumab or nivolumab. Tumor-derived EVs have been linked to cancer proliferation and resistance to these therapies. The Hemopurifier® is designed to remove these EVs from the bloodstream, potentially improving patient responses to anti-PD-1 antibodies.

James Frakes, Interim CEO and CFO of Aethlon Medical, highlighted the company's progress in advancing its oncology trials in Australia and India. The next steps involve obtaining approval from the Research Governance Office at each hospital, followed by Site Initiation Visits. The company anticipates beginning patient enrollment by October 2024.

Frakes also mentioned potential upcoming milestones, including seeking ethics committee approvals at additional sites in Australia and India, with patient enrollment expected by the end of 2024. The primary goal of these trials, involving 9 to 18 patients, is to ensure safety by monitoring adverse events and significant lab test changes in patients treated with the Hemopurifier®. The trials will also assess the number of Hemopurifier® treatments necessary to reduce EV concentration and whether these reductions enhance the body's ability to combat tumor cells.

Beyond oncology, Aethlon is exploring the Hemopurifier® for treating severe viral infections. The device has shown efficacy in capturing various viruses in vitro, including Zika, Lassa, MERS-CoV, and others. The company's COVID-19 trial in India remains open to accommodate potential ICU admissions, with one patient treated so far. Aethlon continues to evaluate the viability and costs of this trial.

Financially, Aethlon reported a cash balance of approximately $9.1 million as of June 30, 2024. Operating expenses for the fiscal quarter were approximately $2.6 million, a 24% reduction compared to the same period in 2023. This decrease was primarily due to lower general and administrative expenses and reduced professional fees. However, there was a slight increase in payroll and related expenses due to separation costs.

Overall, Aethlon Medical's net loss decreased to approximately $2.6 million for the fiscal quarter ending June 30, 2024, compared to approximately $3.3 million in the same quarter of 2023. The company remains focused on advancing its Hemopurifier® trials and exploring additional therapeutic applications.