BioRestorative Therapies Provides First Quarter 2024 Business Update

MELVILLE, N.Y., May 14, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today provided an update on its business.

“We have successfully executed against key strategic priorities since the start of the year,” said Lance Alstodt, BioRestorative’s Chief Executive Officer. “The most important of those were to advance our lead clinical program, BRTX-100, and expand our core preclinical program, ThermoStem, while also laying the groundwork for our commercial BioCosmeceuticals business to start generating significant revenues this year. We expect that this, combined with the $16.4 million cash, cash equivalents, and marketable securities the Company held as of the end of the first quarter, will provide additional financial flexibility.”

Recent Highlights

DEVELOPMENT

Disc/Spine Program

• A poster presented in February at the Orthopaedic Research Society (ORS) 2024 Annual Meeting described preliminary 26 and 52 week blinded data from the ongoing Phase 2 clinical trial of the Company’s lead clinical candidate, BRTX-100, in subjects with chronic lumbar disc disease (“cLDD”). The preliminary clinical data showed meaningful signals in patients enrolled in the study and, importantly, no notable safety signals.
• Following manufacturing/clinical process enhancements made by BioRestorative that tripled its monthly trial capacity, it entered into a collaboration with Galen Patient Recruitment, Inc. designed to support completion of patient enrollment in the Phase 2 BRTX-100 study in cLDD before the end of 2024.
• On the heels of that, the Company announced U.S. Food and Drug Administration (“FDA”) clearance of an important amendment to the Phase 2 study protocol, removing saline injection in the control arm of the study and replacing it with a sham injection.
  
  

Metabolic Program

• Last week, the Company disclosed the development of a novel exosome-based biologic program targeting obesity. The new therapeutic candidate, developed using the Company’s patented ThermoStem platform, has the potential to serve as an adjuvant to existing pharmaceuticals that are FDA approved and marketed towards weight loss. BioRestorative currently anticipates initiating the formal FDA process for this ThermoStem-based therapeutic candidate by filing a Drug Master File (DMF) in the third quarter of 2024, and aims to initiate first-in-human clinical studies before the end of the year.