BioRestorative reports positive data from BRTX-100 stem cell therapy trial

Published 13/06/2025, 12:54
BioRestorative reports positive data from BRTX-100 stem cell therapy trial

NEW YORK - BioRestorative Therapies, Inc. (NASDAQ:BRTX), a clinical-stage biotech company with a market capitalization of $15 million and impressive gross profit margins of 92%, presented preliminary blinded data from its Phase 2 clinical trial of BRTX-100, an autologous stem cell therapy for chronic lumbar disc disease (cLDD), at the International Society for Stem Cell Research Annual Meeting in Hong Kong. According to InvestingPro data, the company’s stock has shown strong momentum with a 10.8% return in the past week.

According to the presentation, data from 36 subjects showed that over 74% achieved more than 50% improvement in function as measured by the Oswestry Disability Index (ODI) at 52 weeks. Additionally, over 72% of subjects reported more than 50% reduction in pain on the Visual Analog Scale (VAS) at the same timepoint. While the clinical results appear promising, InvestingPro analysis reveals the company maintains a healthy current ratio of 2.24, indicating strong short-term financial stability, despite not yet achieving profitability.

The FDA requires greater than 30% improvement in both function and pain reduction for the trial to proceed and ultimately gain approval. No serious adverse events or dose-limiting toxicities were reported between 26 and 104 weeks at the target dose of 40 million cells.

The trial has now evaluated 36 subjects, more than double the 15 subjects in the company’s previous update. The Phase 2 trial is a randomized, double-blinded, placebo-controlled study that will enroll up to 99 subjects at 16 U.S. sites.

BRTX-100 is designed as a non-surgical treatment option for patients with painful lumbosacral disc degeneration. The therapy involves collecting a patient’s bone marrow, isolating and culturing stem cells, and injecting them into the damaged disc in an outpatient procedure.

The company also reported that the percentage of subjects showing combined improvement in both ODI and VAS measures varied across different timepoints in the study, with eight out of 10 subjects showing this improvement at the 52-week mark.

This information is based on a company press release statement. InvestingPro subscribers have access to 16 additional key insights about BRTX, including detailed financial health scores and comprehensive analysis. The Pro Research Report offers in-depth analysis of the company’s growth prospects, with analysts forecasting 210% revenue growth for the current fiscal year.

In other recent news, BioRestorative Therapies Inc. reported its financial results for the first quarter of 2025, showing a widened net loss of $5.3 million, or $0.64 per share, compared to $2.2 million, or $0.33 per share, in the same period last year. Revenue decreased to $25,000 from $35,000 year-over-year, with deferred revenues increasing to $150,000. The company’s cash position remains strong at $9.1 million, with no outstanding debt. Despite these financial challenges, BioRestorative Therapies is advancing its clinical trials, with its lead candidate BRTX-100 for chronic lumbar disc disease currently in Phase II trials. The FDA has granted Fast Track designation for BRTX-100, indicating potential significance in the stem cell therapy market. Analysts noted that the company’s actual earnings per share of -$0.64 missed the forecasted EPS of -$0.26. BioRestorative Therapies continues to explore a potential license agreement for its ThermoStem program.

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