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 metabolic disorders using brown adipose-derived stem cells.

• Integrated CGMP ISO-7 biologics manufacturing facility supports proprietary cell processing and therapeutic technologies.

Clinical pipeline and data

• 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 over 50% of patients achieve >50% improvement in both pain and function at two years post-treatment.

• BRTX-100 offers a single, minimally invasive intradiscal injection, with a strong safety profile and no significant adverse events reported.

• Differentiators include autologous hypoxic-cultured cells, animal-free manufacturing, and autologous platelet lysate carrier.

Market opportunity and commercialization

• 64.5 million U.S. adults suffer from chronic lower back pain; $40 billion spent annually on surgeries.

• Global medical aesthetics market exceeds $35 billion; regenerative products are becoming the new standard.

• BioCosmeceuticals products target both clinical and consumer markets, with distribution through clinics, medspas, and direct-to-consumer channels.

• Multiple high-profile partnerships and commercialization agreements underway, including with Cartessa.

• Regenerative aesthetics market projected to grow from $42B in 2024 to $154B by 2033.