BRTX News & Events

BioRestorative Therapies shareholder Kaos Capital, a Miami-based hedge fund focused on activist investing, has acquired 4.9% of the issued and outstanding common stock of the company. This ownership stake was acquired in the open market through normal course stock purchases. Kaos Capital believes that BRTX represents a compelling opportunity, as the public vehicle may be better positioned for a strategic pivot into the AI space. Kaoss believes that BRTX shareholders are not currently gaining meaningful value from the existing business and that the company should explore a comprehensive strategic review and consider a pivot into a broader range of AI opportunities. Kaos Capital intends to seek an immediate meeting with the Board to discuss the company's strategy, operations, corporate governance, and potential pathways, including a possible pivot into AI.

BioRestorative Therapies announced that the last patient has been dosed in its fully enrolled Phase 2 clinical trial evaluating BRTX-100 for the treatment of chronic lumbar disc disease, completing treatment administration in the Company's lead clinical program and advancing the study into the next stage of blinded follow-up ahead of expected topline safety and efficacy data in Q2 2027. The prospective, randomized, double-blind, sham-controlled, single-disc Phase 2 study enrolled approximately 99 patients across U.S. clinical sites and is designed to evaluate the safety and preliminary efficacy of BRTX-100 in patients with painful chronic lumbar disc disease. Subjects were randomized in a 2:1 ratio to receive either BRTX-100 or control treatment. The primary safety endpoints for the trial include the frequency and severity of adverse events and serious adverse events, as well as imaging-related findings. The primary efficacy responder endpoint is defined as at least a 30% improvement from baseline in both pain -- as measured by the Visual Analog Scale -- and function --as measured by the Oswestry Disability Index, at week 52. Study follow-up assessments are being conducted at weeks 2, 12, 26, 52 and 104, with MRI evaluations at baseline, week 52 and week 104.

BioRestorative Therapies announces the presentation of new preclinical data at the International Society for Cell & Gene Therapy 2026 Annual Meeting, which took place May 6-9 in Dublin, Ireland. The data highlight the functional and proteomic differences of extracellular vesicles, including exosomes, derived from multiple mesenchymal stem cell sources. Detailed in an oral presentation titled, "MSC Exosome Proteomics Reveal Source-Specific Therapeutic Applications," the study demonstrates that EVs derived from distinct MSC sources, including umbilical cord, brown adipose tissue, and bone marrow, exhibit unique protein signatures and biological functions that may enable targeted therapeutic and commercial applications. The data were presented on May 6, 2026. Proteomic and gene ontology analyses revealed several key functional pathways associated with specific MSC-derived EV populations:Proliferation and regenerative signaling: Enrichment in RNA and mRNA metabolic processes supports cellular growth, tissue regeneration, and remodeling; Cell adhesion and immune modulation: Enhanced signaling related to cell-substrate adhesion, phosphorylation, and immune response regulation supports extracellular matrix remodeling, wound healing, and inflammation control; Epidermal differentiation and barrier formation: Enrichment in keratinization and cornification pathways supports skin barrier repair, scar modulation, and keratinocyte function. Collectively, these findings support the development of differentiated EV-based formulations tailored to specific applications within regenerative aesthetics and dermatology, providing a framework for aligning source-specific biological activity with targeted clinical and commercial use cases. The Company believes these functional insights have direct implications for its BioCosmeceutical platform, enabling the design of targeted product formulations across a range of aesthetic and dermatologic use cases, including: Skin rejuvenation and anti-aging applications, leveraging regenerative signaling to support collagen production and epidermal renewal; Post-procedural recovery solutions, designed to accelerate healing and reduce inflammation following aesthetic treatments; Scar and wound repair formulations, supporting improved tissue remodeling and barrier; restoration; Barrier repair and hydration therapies, aimed at improving skin integrity and reducing trans-epidermal water loss Hair and scalp health applications, targeting follicle activation and regenerative signaling pathways.

BioRestorative Therapies announced expanded blinded data from its fully enrolled Phase 2 clinical trial evaluating BRTX-100, the Company's autologous hypoxic-cultured mesenchymal stem cell therapy for the treatment of chronic lumbar disc disease. The data were presented in an oral presentation at the International Society for Cell & Gene Therapy Annual Meeting on May 6, 2026, at The Convention Centre Dublin in Dublin, Ireland. The presentation, titled "Late-Stage Phase 2 Clinical Safety and Efficacy Data on Intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells: Study Update," included a larger 52-week follow-up cohort than previously reported and continued to show clinically meaningful improvements across validated pain and functional outcome measures. 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. At 52 weeks, 52% of evaluable patients achieved at least 50% improvement in both the Visual Analog Scale for pain and the Oswestry Disability Index for function. The number of patients evaluated at 52 weeks more than doubled compared with the Company's previously reported ORS 2026 dataset, increasing from 12 patients to 25 patients, while continuing to show favorable safety outcomes and no adverse events related to dose-limiting toxicities associated with hypoxic-cultured mesenchymal stem cells. The Phase 2 study is designed to evaluate, among other measures, pain reduction using VAS and functional improvement using ODI at 52 weeks. The study's efficacy criteria include at least a 30% decrease in pain and at least a 30% improvement in function at 52 weeks. The blinded ISCT dataset showed that a substantial portion of evaluable patients exceeded that threshold, achieving at least 50% improvement across key measures. Clinically meaningful improvements in both pain and functional outcomes were observed across multiple validated pain and function measures, including the VAS, ODI, Roland-Morris Disability Questionnaire, and Functional Rating Index, with responses sustained for up to two years in patients with longer-term follow-up. Specifically: On VAS for pain, 56% of evaluable patients reported at least 50% improvement at 52 weeks, with an average improvement of 71.4%. At 104 weeks, average improvement increased to 73.8%. On ODI, a widely used measure of functional impairment associated with spinal disorders, 64% of evaluable patients achieved at least 50% improvement at 52 weeks, with an average improvement of 73.6%. At 104 weeks, average improvement was 68%. At 52 weeks, 52% of evaluable patients achieved at least 50% improvement in both VAS and ODI, a combined measure reflecting simultaneous improvement in pain and function. On FRI, 56% of evaluable patients reported at least 50% improvement at 52 weeks, with an average improvement of 69.7%. At 104 weeks, average improvement was 58.6%/ On RMDQ, 56% of evaluable patients experienced at least 50% improvement at 52 weeks, with an average improvement of 85.9%. At 104 weeks, average improvement was 73.6%