AEMD: Positive Takeaways from Plan to Expand Clinical Efforts

NASDAQ:AEMD

Several medical centers actively screening patients for enrollment

Aethlon Medical AEMD hosted a call and provided a business update yesterday. 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. The company has two studies of the Hemopurifier that are underway: one in severely ill COVID-19 patients and the other in patients with head and neck cancer.

The company noted the strong progress it is making advancing its existing clinical trials and management's expectation to expand the study of the Hemopurifier® in additional clinical trials. Our key takeaways regard initiatives the company has implemented to move the device forward, including expanding the senior management team and broadening its healthcare expertise, improving the cash position to support growth measures and clinical trials, and securing a well-regarded CRO to facilitate clinical studies, among other initiatives.

The Hemopurifier is a therapeutic blood filtration system, as noted, that can bind and remove life-threatening viruses and harmful exosomes from blood. Of importance, we believe, is that given that the Hemopurifier has been shown to clear exosomes and viruses from the blood, as noted, the device is expected to have multiple applications. Potential applications include in a variety of cancers, where cancer associated exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases, including removal of COVID-19 virus, associated variants, and related exosomes.

Evaluating the Hemopurifier in COVID-19 and a range of viral conditions...

The Hemopurifier has already demonstrated binding of SARS-CoV-2 spike protein, including binding and removing the SARS-CoV-2 virus from the circulation of human patients, including demonstrating the removal of exosomes and exosomal microRNAs associated with coagulopathy and acute lung injury. The Hemopurifier has demonstrated clearance of many different viruses in vitro, including HIV, dengue, West Nile, influenza, Ebola, herpes and MERS.

Regarding the domestic Severe COVID trial, AEMD now has three hospitals participating in the study:

❖ Hoag Newport Beach

❖ Hoag Irvine

❖ Loma Linda Medical Center

All these venues are fully open for patient enrollment and are actively screening patients for the trial, according to management. The company also expects to open an additional five centers (UC Davis, LSU Shreveport, Thomas Jefferson Medical Center, University of Miami and Valley Baptist Medical Center) shortly to enroll patients in the study. AEMD and PPD, the company's CRO, are also in discussions to include other leading U.S. medical centers in the study.

The company has also completed all site initiation activities at Medanta Medicity Hospital in India for its planned Severe COVID-19 clinical trial there. Medanta Medicity Hospital is now open for enrollment and is actively screening patients for the trial. AEMD management has worked with the medical center and the lead investigator in the past, which is expected to facilitate patient enrollments and training of medical staff to conduct the trial.

… and expanding clinical efforts to evaluate the Hemopurifier in multiple cancer studies

AEMD also continues to screen patients for its IDE clinical trial in Head and Neck Cancer. Given the Hemopurifier's demonstrated ability to remove exosomes, management believes the device can be used to affect improved outcomes in a number of cancers. Based on management's comments, we expect AEMD to initiate additional trials domestically and internationally to study the Hemopurifier as a treatment for other forms of cancer. Keytruda, the standard of care with which the Hemopurifier is being evaluated, has been used to treat 25+ different types of cancer.

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