AEMD: Strong balance sheet, expanded management team & new CRO relationship expected to facilitate clinical efforts

By M. Marin

NASDAQ:AEMD

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Positive takeaways regarding AEMD's initiatives to advance the Hemopurifier

Aethlon Medical AEMD hosted a call and provided a business update earlier this week. 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.

Our key positive takeaways regarding initiatives the company has implemented to move the device forward are: the company has expanded the senior management team and broadened its healthcare expertise, improved the cash position to support growth initiatives and clinical trials, and secured a well-regarded CRO to facilitate clinical studies, among other measures.

Expanded senior management team adds industry and medical expertise

Over the past several quarters, Aethlon has expanded its executive team in order to support the many opportunities the company expects to leverage. 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. Specifically, Guy Cipriani was named SVP and Chief Business Officer. He is responsible for business development and partnerships and involved in fundraising and corporate development.

Steven LaRosa, M.D., has become AEMD s Chief Medical Officer, with responsibility for the clinical development of the Hemopurifier®. Both have significant industry experience. In the aggregate, this management team has more than a century of healthcare experience.

The company also recently hired a consultant physician who has substantial experience managing critically ill patients and has treated myriads of critically COVID-19 patients in the ICU and a critical care nurse who has extensive experience treating severe COVID-19 cases.

Balance sheet: improved cash position to support growth initiatives and clinical trials

AEMD finished 2Q of fiscal 2022 with a strong balance sheet. The company had about $23.2 million in cash and no debt. In June 2021, AEMD raised an aggregate roughly $17.5 million, consisting of about $5 million through sales under its ATM agreement and over $11 million in a registered direct financing, plus the exercise of warrants. The funds enhance the company's financial flexibility to advance clinical trials and move the Hemopurifier towards potential regulatory approval and commercial launch, in our view.

AEMD also has been adept at leveraging National Cancer Institute (NCI) and government funding for research studies, as noted above. The combination of cash on hand and government grands and awards is expected to help AEMD continue to advance and build inventory of the Hemopurifier for the two studies that are currently ongoing.

New CRO to facilitate clinical studies

AEMD recently finalized its selection of a CRO (Contract Research Organization) to supervise these and potentially other clinical trials shortly. In September, AEMD entered into an agreement with PPD, a publicly-traded, leading CRO that has extensive experience and a global footprint. PPD is overseeing the company's clinical studies investigating the Hemopurifier for infectious disease indications and will manage the study of the Hemopurifier for patients who are critically ill with COVID-19 and potentially additional studies.

Reflecting PPD's substantial experience and prior work history with some members of AEMD senior management over the years, AEMD is optimistic that PPD will move the study forward in an efficient and expedient way. Working with PPD, which the company believes has assembled a strong team to facilitate the U.S. COVID-19 study, AEMD continues to advance site readiness at medical centers participating in the study.

Oncology study moving forward; potentially expanding to study the Hemopurifier in the broader cancer space

AEMD recently provided a refresher training session at the University of Pittsburgh Medical Center (UPMC), as it moves the cancer study forward and enrolls patients from UPMC and affiliated institutions. AEMD is also exploring other tumor types for opportunities to study the potential benefits of the hemopurifier in the broader cancer space, given the Hemopurifier's demonstrated ability to remove exosomes.

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