AEMD: Expanding Research Efforts & Strengthening Team, While Minimizing R&D Spending

By M. Marin

NASDAQ:AEMD

READ THE FULL AEMD RESEARCH REPORT

Strengthening team with recently added CSO & new board member…

Aethlon Medical (NASDAQ:AEMD) has strengthened its team with the recent addition of a new CSO (Chief Scientific Officer) and new board member. Moreover, the company continues to focus on maximizing R&D spending in order to advance the Aethlon Hemopurifier®, its lead product. The current focus for clinical studies of the HemoPurifier is in the areas of oncology, followed by infectious disease. Aethlon is launching a blanket oncology study in Australia and considering an oncology trial in India, where it has a trial studying the Hemopurifier to treat severe COVID-19. By transitioning its clinical efforts to Australia & India, AEMD expects its R&D spending will go further, reflecting lower costs in both markets and attractive economic incentives offered in Australia.

Recent initiatives include:

▪ Pivoting clinical efforts to Australia & India, where AEMD expects clinical spending will go further

▪ Launching blanket oncology study in Australia

▪ Obtaining approval for a 2nd hospital site for Sars-Cov-2 clinical trials in India

▪ Forming a materials transfer agreement to study the Hemopurifier in “Long COVID-19”

▪ Launching translational studies researching the use of our Hemopurifier in organ transplants

▪ Adding new CSO & board member with extensive medical device experience

… while expanding research efforts…

AEMD also intends to research the Hemopurifier’s application to improve outcomes of organ transplants. The company recently announced an initiative to determine the Hemopurifier’s ability to improve the outcomes of organ transplantation in addition to its existing cancer and COVID-19 studies. Aethlon will investigate the Hemopurifier’s ability to remove viruses and exosomes from harvested organs to increase the number of organs that can be transplanted successfully.

The company will study whether the Hemopurifier can remove viruses and exosomes from harvested organs when it is incorporated into a machine perfusion organ preservation circuit. In vitro studies using a scaled-down version of the Hemopurifier demonstrated the removal of multiple viruses and exosomes from buffer solutions. The company believes that if the Hemopurifier can remove these substances from the organs, the device could lower the risk of complications following transplantation, including potentially viral infection, delayed graft function and organ rejection. The company’s objective is to position the Hemopurifier as an additive way to increase the supply of viable organs available to be transplanted. Currently, the global transplantation market is in the multiple billions of dollars and is expected to grow substantially, driven by the aging of the population, higher rates of organ failure as people age and improvements in organ preservation and transplant procedures, among other factors.

… and optimizing R&D spending …

The company’s goal is to maximize its R&D spending to advance the Hemopurifier. By recently shifting its clinical efforts to Australia and India for now, the company expects to maximize its R&D dollars. AEMD expects to realize benefits from attractive economic incentives the Australian government provides for clinical development efforts and lower costs in India, where R&D expenses are substantially lower than in the U.S., according to management. AEMD believes its recent initiatives can boost the company’s potential to receive regulatory approval and funding to advance clinical research and accelerate time to market.

New Chief Scientific Officer…

The company also recently named Lee Arnold, PhD. as its new Chief Scientific Officer. Dr. Arnold has 36 years of experience in molecularly-targeted drug discovery and has worked in big pharma and several start-up biotech firms. He began his career in pharma research at Syntex, Inc. and also has worked at Pfizer, OSI Pharmaceuticals and BASF, among other big pharma companies. Prior to joining Aethlon, he was the CSO and cofounder of Pardes Biosciences, Inc., which was launched as the COVID pandemic got underway. Pardes Bioscience discovered and advanced the oral protease inhibitor, pomotrelvir, into clinical trials for SARS-CoV2. Overall, his experience and leadership contributions have resulted in an approved drug, and 16 additional development candidates undergoing clinical trials in oncology, immunology and virology.

At Pfizer, he invented Tarceva® (erlotinib) for non-small cell lung cancer. At BASF/Abbott Bioresearch Center, he launched and headed two multinational multidisciplinary projects in angiogenesis that ultimately resulted in linifanib (ABT-869). As VP of Research at OSI Pharmaceuticals, his teams discovered four oncology development candidates, including linsitinib (IGF-1R), and ASP7486 (TORC1/2). He has authored multiple papers in the areas of biophysics and biochemistry.

… New Board Member

Aethlon also appointed Nicolas Gikakis to its board, thereby increasing the board to six members. He has extensive experience as an executive in the global medical device and biomedical industry. The company is optimistic that it can leverage his knowledge and relationships. From 2021 to May 2023, was Head of Commercial for a private Australian medical device and digital health company, WearOptimo Pty Ltd. Prior to that from 2017 to 2019, he was VP of Strategy and Corporate Development at a private medical device company, Oventus Medical Limited, where he helped with the commercial expansion of the company’s sleep apnea device. From 2012 to 2021, he held various roles in sales, marketing, product development, and corporate development and transactions in the healthcare industry, including for companies that worked with blood filtration and purification as the Hemopurifier does.

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