Aethlon Medical, a medical company focused on developing treatments for cancer and life-threatening infectious diseases, reported its fiscal year-end results for March 31, 2024. The company is advancing its blood purification device, which is designed to remove harmful foreign bodies and deadly viruses from blood and other biological fluids. This technology holds potential applications in oncology, where extracellular vesicles (EVs) may contribute to immune suppression and metastasis, as well as in life-threatening infectious diseases.
Key developments include:
- Approval by the Adelaide Central Local Health Network's Human Research Ethics Committee for a clinical trial to assess the safety, feasibility, and dose finding of the blood purification device in cancer patients undergoing anti-PD-1 single therapy, such as Keytruda or Opdivo.
- The trial aims to determine the efficacy of the device in enhancing the response rate to anti-PD-1 antibodies by reducing EV concentrations in patients with stable or progressive solid tumors.
- Aethlon Medical expects to recruit and treat the first patient in the third or fourth quarter of 2024 after securing approval from the Australian National Health Regulatory Authority, receiving approval from the CALHN Research Governance Committee, and conducting initial site visits.
- The company has received FDA approval for an internal production facility, enabling the manufacture of sufficient blood purification devices for clinical trials.
- Aethlon Medical is also utilizing the blood purification device as a treatment for COVID-19 infections in India, with one patient treated so far, and plans to submit additional sites to ethics committees for further recruitment.
Financial highlights for the fiscal year ending March 31, 2024, showed a cash balance of approximately $5.4 million, rising to $9.1 million by June 25, 2024. Operating expenses for the fiscal year were about $12.6 million, up from $12.5 million in the previous fiscal year, primarily due to increased salary and related costs offset by reduced general and administrative expenses, professional fees, and others.
The net loss for the fiscal year was $12.2 million, compared to $12.0 million in the previous fiscal year. The company anticipates several upcoming milestones, including approvals at additional sites in Australia and India, which could lead to patient recruitment later in 2024.
In terms of corporate structure, Aethlon Medical had total assets of $8.2 million, total liabilities of $2.5 million, and shareholders' equity of $5.7 million as of March 31, 2024. The company's financial performance and recent developments will be discussed in detail during a conference call scheduled for June 27, 2024, at 4:30 PM Eastern Time.