BRTX News & Events

Rodman & Renshaw LLC is acting as the exclusive placement agent for the offering. The gross proceeds to the Company from the offering are expected to be approximately $5.0 million, before deducting the placement agent's fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for its clinical trials with respect to BRTX-100, pre-clinical research and development with respect to its ThermoStem Program, the development of its commercial biocosmeceuticals platform and for general corporate purposes and working capital.

BioRestorative Therapies, provided an update following the feedback received from the FDA regarding a potential expedited Biologics License Application approval pathway for the Fast-Track-Designated BRTX-100 program for the treatment of chronic lumbar disc disease, based on a Type B meeting requested by the Company. "The positive outcome of our Type B meeting with the FDA provides the clarity needed to support a pathway to expedited BLA approval for our BRTX-100 program in cLDD," said Lance Alstodt, CEO. "In addition, we believe the fact that we can prepare and submit the Phase 3 IND application ahead of unblinding the ongoing Phase 2 trial is a testament to the excellent safety profile and upward trend in efficacy endpoints demonstrated to-date." Based on ongoing activities, the Company currently anticipates that the Phase 3 trial IND submission will be made in the second half of 2026.

BioRestorative Therapies announced completion of patient enrollment in its Phase 2 clinical trial evaluating the safety and efficacy of BRTX-100 for the treatment of chronic lumbar disc disease, cLDD. The trial utilizes a prospective, randomized, double-blind, sham-controlled design focused on single-disc disease, widely considered the gold standard for clinical rigor in spine intervention studies. Participants were randomized 2:1 to receive either BRTX-100 or placebo through a minimally invasive outpatient intradiscal procedure. The primary safety endpoint for the Phase 2 clinical trial of BRTX-100 in cLDD is the frequency and severity of adverse events. The primary efficacy endpoints of the trial are a greater than 30% improvement in function in the Oswestry Disability Index and a greater than 30% reduction in pain on the Visual Analog Scale vs. baseline at week 52.

The company is offering up to 9.71M units, each consisting of one share of common stock, and one warrant, each warrant to purchase one share of common stock, at an assumed public offering price of $1.03 per unit, for gross proceeds of approximately $10M. Rodman & Renshaw is acting as the underwriter for this offering.