BioRestorative Therapies (BRTX) investor relations material

Company overview and platform

• Clinical-stage regenerative medicine company focused on cell-based therapies for spine disorders, metabolic diseases, and regenerative aesthetics.

• Lead asset BRTX-100 is in late-stage Phase 2 for chronic lumbar disc disease, using autologous bone marrow-derived mesenchymal stem cells.

• BioCosmeceuticals platform commercializes secretome-derived skincare products for professional and at-home use.

• ThermoStem preclinical program targets obesity and Type 2 diabetes using brown adipose-derived stem cells.

Clinical pipeline and programs

• BRTX-100 Phase 2 trial fully enrolled, with FDA Fast Track designation and topline data expected in spring 2027.

• Phase 2 design: 105 subjects, 2:1 randomization, single diseased disc, primary endpoints are ≥30% improvement in function and pain.

• Preliminary Phase 2 data show sustained efficacy, with over 50% of patients achieving significant pain and function improvement at two years.

• ThermoStem program completed proof-of-concept in animal models, showing reduced glucose and weight in obese mice.

• BioCosmeceuticals advancing commercialization with multiple distribution channels and partnerships.

Market opportunity and differentiation

• 64.5M U.S. adults suffer from chronic lower back pain; $35B+ global medical aesthetics market.

• BRTX-100 offers a non-invasive, single-injection alternative to costly and invasive surgeries.

• Autologous, hypoxic-cultured cells and platelet lysate carrier differentiate BRTX-100 from allogeneic competitors.

• Regenerative aesthetics market is rapidly growing, with a shift toward biotech-led, clinically validated products.