By M. Marin
1Q FY 2022 Results
Aethlon Medical (NASDAQ:AEMD) announced results for 1Q FY 2022 (fiscal year ends March) and provided a business update. AEMD generated total revenue of about $132,000. Roughly $115,000 was from government contracts related to AEMD’s phase 2 melanoma cancer contract. In addition, the company recorded revenue of about $17,000 related to the cost reimbursable sub-award arrangement that AEMD has with the University of Pittsburgh associated with an NIH contract.
The company’s lead product is the Hemopurifier, an extracorporeal (i.e. outside of the body) blood filtration device that is designed to selectively remove harmful particles from the circulatory system. Aethlon has expanded its executive team in order to support the many opportunities the company has for the Hemopurifier. For instance, in October 2020, AEMD appointed Charles J. Fisher, Jr., M.D. as CEO. He has extensive experience in developing and commercializing new assets. AEMD also hired a new Chief Business Officer and new Chief Medical Officer who together have a combined nearly 40 years of industry experience.
… Enhanced financial flexibility
Importantly, AEMD finished 1Q fiscal 2022 with about $25.2 million in cash and no debt. In June 2021, AEMD raised an aggregate roughly $17.3 million. The funds enhance the company’s financial flexibility to advance clinical trials and move the Hemopurifier towards potential regulatory approval and commercial launch.
… To Advance Two Studies
AEMD has two Early Feasibility Studies (EFS) of the Hemopurifier underway: one treating COVID patients and one treating patients with head and neck cancer. With two different studies of different diseases, we believe AEMD potentially has expanded the commercial opportunity for the device and possibly shortened the path to approval.
The COVID study is extremely timely, given the increase in the number of COVID cases. In 1Q FY 2022, New Jersey-based Cooper Medical Center joined the trial. Cooper Medical Center is one of the leading academic health systems in South New Jersey. AEMD is also in advanced discussions with other key U.S. and international medical centers to potentially join the clinical trial.
Moreover, the Hemopurifier® positive results in treating two critically ill COVID-19 patients augment the database of the Hemopurifier’s clinical benefits:
➢ Successfully cleared SARS-CoV-2 virus from the blood stream.
➢ Successfully cleared associated exosomes from the blood stream.
➢ Patients tolerated Hemopurifier treatment without side effects
➢ Lowered noxious exosomal microRNAs associated with coagulopathy and acute lung injury
We believe the company continues to build its database of positive outcomes using the Hemopurifier. Over the years, AEMD has demonstrated that the Hemopurifier binds and removes glycosylated – or sugar coated – viruses. The Hemopurifier captures enveloped viral pathogens and exosomes in the circulating bloodstream, based on size and glycosylation, and removes them. The Hemopurifier has demonstrated clearance of many different viruses in vitro, including HIV, dengue, West Nile, influenza, Ebola, herpes and MERS.
The company believes the Hemopurifier can be applied to COVID-19 and potentially a range of other conditions. We believe the Hemopurfier results with the two COVID-19 patients noted above point to the potential versatility of the Hemopurfier that could, in turn, also imply a growing commercial opportunity for AEMD’s device.
The other clinical trial is an important study of patients with head and neck cancer exploring the impact of clinical depletion of exosomes using the Aethlon Hemopurifier along with standard of care treatment, Keytruda®. The company continues to work closely with the University of Pittsburgh Human Cancer Center, its principal investigator in the head and neck program, to continue enrolling patients in the EFS trial.
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