BRTX News & Events

BioRestorative Therapies announced blinded data from its Phase 2 clinical trial evaluating hypoxic-cultured mesenchymal stem cells for the treatment of chronic lumbar disc disease, with 50% or more of treated patients reporting improvements greater than 50% across key pain and functional outcome measures and no adverse events related to dose-limiting toxicities. Importantly, the Phase 2 study efficacy endpoint is a greater than a 30% improvement in both the Visual Analog Scale and Oswestry Disability Index at 52 weeks, which is the minimum improvement needed to meet clinical efficacy success. Chronic lumbar disc disease is a leading cause of chronic lower back pain and disability, affecting millions of patients globally and representing a significant unmet need for non-surgical regenerative therapies. These data were presented at the 2026 Orthopaedic Research Society annual meeting on March 28 at the Charlotte Convention Center in Charlotte, North Carolina. Clinically meaningful improvements in both pain and functional outcomes were observed across multiple validated pain and function measures, including the Visual Analog Scale, Oswestry Disability Index, Roland-Morris Disability Questionnaire, and Functional Rating Index, with responses sustained for up to two years in patients with longer-term follow-up. On the VAS for pain, 53.57% of patients reported greater than 50% improvement at 26 weeks, with the percentage of patients that reported greater than 50% improvement increasing to 75% at 52 weeks and remaining 75% at 104 weeks. Similar improvements were observed on the ODI, a widely used measure of functional impairment associated with spinal disorders. Blinded results from the abstract showed 53.57% of patients achieved greater than 50% improvement at 26 weeks, increasing to 74.63% of patients at 52 weeks, with 50% of patients maintaining that level of improvement at 104 weeks. Improvements were also observed on the RMDQ, with 57.14% of patients experiencing greater than 50% improvement at 26 weeks, 50% of patients at 52 weeks, and 75% of patients at 104 weeks. FRI demonstrated continued improvement over time, with 35.71% of patients achieving greater than 50% improvement at 26 weeks, increasing to 66.67% of patients at 52 weeks and 50% of patients at 104 weeks. Finally, at 26 weeks 41% of patients reported a 50% improvement in both ODI and VAS, 55% of patients achieved a 50% improvement in both ODI and VAS at 52 weeks, and at 104 weeks 57% of patients met a 50% improvement in both ODI and VAS.

BioRestorative Therapies issued the following letter to shareholders from Chief Executive Officer Lance Alstodt: "The first quarter of 2026 marks a pivotal period for BioRestorative Therapies. We have achieved significant milestones and have strong momentum across our clinical programs, regulatory pathways, commercial initiatives, and capital strategy. We believe the Company is well-positioned at a meaningful value inflection point, supported by: Completion of enrollment in our fully powered Phase 2 trial of BRTX-100; Positive Type B regulatory outcome and alignment on the BLA pathway; Initiation of Phase 3 enabling activities; Strengthened capital position following a $5 million public offering; Acceleration of our commercial BioCosmeceutical strategy; Continued development of our ThermoStem metabolic platform... Following our recent $5 million public offering, we have strengthened our balance sheet and extended our operational runway. We are focused on maintaining optionality, advancing BRTX-100 through key data readouts, and preserving leverage ahead of potential partnership discussions... Our primary focus in 2026 is advancing BRTX-100 into late-stage development with regulatory clarity and operational readiness for BLA approval. This includes the initiation of Phase 3 enabling activities, the refinement of protocol elements consistent with prior FDA feedback, the confirmation of manufacturing readiness, and the submission of the Phase 3 IND amendment, targeted for the second half of 2026... We intend to report Phase 2 topline results in early 2027 in accordance with the pre-specified statistical analysis plan... Outside the United States, commercial applications of cell-based biologics, such as stem cells, have advanced significantly over the past several years and have continued to grow in 2026... Our BioCosmeceutical platform will continue to be developed with a focus on operational execution and margin discipline... We believe BioRestorative is transitioning from development-stage uncertainty toward late-stage regulatory clarity. Our focus remains on execution, data integrity, capital efficiency, and long-term shareholder value."

BioRestorative Therapies announced that IP Australia, the intellectual property branch of the Australian government, has allowed Patent Application No. 2020265664 titled, "Non-naturally occurring three-dimensional brown adipose-derived stem cell aggregates, and methods of generating and using the same." The newly allowed patent application provides the broadest protection obtained for BioRestorative's allogeneic, off-the-shelf, brown adipose-derived stem cell ThermoStem technology, designed to treat obesity and metabolic disorders. The claims covered are: a method of making a non-naturally occurring three-dimensional brown adipose derived stem cell aggregate.

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.