BioRestorative Therapies Enhances Preclinical Metabolic Program with a Novel Exosome-Based Biologic Targeting Obesity

— New therapeutic candidate developed using Company’s patented ThermoStem platform —

— Candidate has potential to serve as an adjuvant to existing pharmaceuticals that are FDA approved and marketed towards weight loss —

— DMF submission and commencement of first-in-human studies targeted for before the end of 2024 —

— Expanding the use of ThermoStem may open the door to big pharma partnership opportunities —

MELVILLE, N.Y., May 08, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced its development of a novel exosome-based biologic program targeting obesity.

BioRestorative currently anticipates initiating the formal U.S. Food and Drug Administration (“FDA”) process for this ThermoStem-based therapeutic candidate by filing a Drug Master File (“DMF”) in the third quarter of 2024. The Company aims to initiate first-in-human clinical studies before the end of the year.

Exosomes are small extracellular vesicles secreted by various cells, including stem cells. They are understood to be important mediators of intercellular communication, and have been found to play a role in adipose (fat) metabolism by transporting cargo, such as non-coding RNAs (ncRNA), proteins, and other factors that may impact weight loss. Previously published peer-reviewed preclinical data from a study conducted in collaboration with the University of Utah School of Medicine demonstrated that functional brown adipose derived stem cells, formulated using BioRestorative’s proprietary ThermoStem platform, produced significant reductions in weight (consistent with losses achieved by GLP1 drugs) and blood glucose levels in a diet induced obesity model in mice.

BioRestorative’s ThermoStem platform has a comprehensive portfolio of issued patents that cover both the U.S. and international markets. This broad intellectual property portfolio can be leveraged across drugs that are currently approved and marketed for weight loss, potentially opening the door to future big pharma partnership opportunities for the Company.

“We believe that our proprietary ThermoStem technology platform has immense potential to develop both best-in-class and first-in-class therapies to treat obesity, such as this exosome-based biologic candidate,” said Lance Alstodt, BioRestorative’s Chief Executive Officer. “While tremendous progress has been made in the fight against obesity, there is no question that significant unmet need remains. As an adjuvant to approved and marketed weight loss drugs, we believe that our new therapeutic candidate may allow for lower dosing, as well as prevent or minimize potential of muscle mass loss and negative cardiovascular effects.”